MedWorm: Advair

Corticosteroid insensitivity is reversed by formoterol via phosphoinositide 3 kinase inhibition

British Journal of Pharmacology — Tue, 17 Jan 2012 05:00:00 +0100

Conclusions and Implications. FM reversed oxidative stress‐induced corticosteroid insensitivity and decreased β2 receptor dependent cAMP production via inhibition of PI3Kδ signalling. A combination of a corticosteroid with FM will be more effective than that with SM under conditions of high oxidative stress, such as in COPD. (Source: British Journal of Pharmacology)

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Effects of intranasal salmeterol and fluticasone given alone and in combination in persistent allergic rhinitis.

Annals of Allergy, Asthma and Immunology — Fri, 30 Dec 2011 11:39:20 +0100

CONCLUSION: Chronic dosing with fluticasone but not salmeterol confers anti-inflammatory activity against nasal AMP challenge, but there was no potentiation of fluticasone when given in combination with salmeterol. Thus, salmeterol may not be an effective treatment for use in allergic rhinitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01388595. PMID: 22192967 [PubMed - in process] (Source: Annals of Allergy, Asthma and Immunology)

Inhaled corticosteroids versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.

Cochrane Database of Systematic Reviews — Tue, 20 Dec 2011 01:00:04 +0100

CONCLUSIONS: Placebo-controlled trials have established the benefits of both long-acting beta-agonist and inhaled corticosteroid therapy for COPD patients as individual therapies. This review, which included trials allowing comparisons between LABA and ICS, has shown that the two therapies confer similar benefits across the majority of outcomes, including the frequency of exacerbations and mortality. Use of long-acting beta-agonists appears to confer a small additional benefit in terms of improvements in lung function compared to inhaled corticosteroids. On the other hand, inhaled corticosteroid therapy shows a small advantage over long-acting beta-agonist therapy in terms of health-related quality of life, but inhaled corticosteroids also increase the risk of pneumonia. This review suppor...

Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children.

Cochrane Database of Systematic Reviews — Tue, 20 Dec 2011 01:00:04 +0100

CONCLUSIONS: Statistical imprecision in the effect estimates for exacerbations and serious adverse events do not enable us to conclude that either therapy is superior. The uncertainty around the effect estimates justify further trials to provide more definitive conclusions; the overall quality of evidence based on GRADE recommendations for the three primary outcomes and withdrawals due to serious adverse events was moderate. We rated the quality of evidence for mortality to be low. Results for lung function outcomes showed that the drugs were sufficiently similar that further research is unlikely to change the effects. No trials were identified in the under-12s and research in this population is a high priority. Evaluation of quality of life is a priority for future research. PMID: 221...

Ciclesonide Safe, Effective for Asthma Ciclesonide Safe, Effective for Asthma

Medscape Today Headlines — Fri, 09 Dec 2011 18:12:25 +0100

New study shows that patients receiving low-dose fluticasone propionate/salmeterol can be safely switched to ciclesonide. Medscape Medical News (Source: Medscape Today Headlines)

Fluticasone propionate and Salmeterol combination induces SOCS-3 expression in airway epithelial cells.

International Immunopharmacology — Wed, 07 Dec 2011 05:00:00 +0100

Authors: Nasreen N, Khodayari N, Sukka-Ganesh B, Peruvemba S, Mohammed KA Abstract Fluticasone propionate (FP) and Salmeterol (SAL) are commonly used in combination therapy for patients with Chronic obstructive pulmonary disease (COPD). Clinical studies show that FP/SAL used in combination therapy was found to inhibit airway inflammation in COPD patients. However, the mechanisms associated with FP/SAL induced anti-inflammatory effects were not clear. We have evaluated the effect of FP/SAL and tobacco smoke (TS) on SOCS-3 and interleukine-6 expression in bronchial airway epithelial cells (BAEpCs). Human BAEpCs were exposed to TS and subsequently treated with FP or SAL alone or in combinations in the presence and absence of mitogen activated protein kinase (MAPK) inhibitors for eithe...

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An Oral Inhibitor of p38 MAP Kinase Reduces Plasma Fibrinogen in Patients With Chronic Obstructive Pulmonary Disease.

The Journal of Clinical Pharmacology — Wed, 16 Nov 2011 05:00:00 +0100

Authors: Lomas DA, Lipson DA, Miller BE, Willits L, Keene O, Barnacle H, Barnes NC, Tal-Singer R Abstract The aims were to determine the effect of an oral inhibitor of the signaling mediator p38 mitogen-activated protein kinase (GW856553, losmapimod) on sputum neutrophils, pulmonary function, and blood biomarkers of inflammation in chronic obstructive pulmonary disease (COPD). Three hundred and two individuals with GOLD stage II COPD were randomized to oral losmapimod 7.5 mg twice daily, inhaled salmeterol/fluticasone propionate 50 μg/500 μg combination (SFC), or placebo in a 12-week, randomized, double-blind, double-dummy study (MKI102428/NCT00642148). Neither losmapimod nor SFC had an effect on the primary end point of sputum neutrophils. Losmapimod was well tolerated and reduc...

Mylan to Acquire Pfizer Respiratory Delivery Platform

Drugs.com - Pharma News — Wed, 09 Nov 2011 14:04:48 +0100

Fills another important gap in Mylan's product portfolio Includes global rights to generic Advair® Diskus and Seretide® Diskus PITTSBURGH, Nov. 9, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into an... (Source: Drugs.com - Pharma News)

Mylan To Acquire Pfizer Respiratory Delivery Platform

Pharmaceutical Online News — Wed, 09 Nov 2011 07:57:00 +0100

Mylan Inc. (Nasdaq: MYL) today announced that it has entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize Pfizer's generic equivalent to GlaxoSmithKline's Advair® Diskus and Seretide® Diskus incorporating Pfizer's proprietary dry powder inhaler delivery platform. (Source: Pharmaceutical Online News)

Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD

Respiratory Medicine — Mon, 31 Oct 2011 04:00:00 +0100

Conclusions: The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events. NCT00784550. (Source: Respiratory Medicine)

Relationship between the anti-inflammatory properties of Salmeterol/Fluticasone and the expression of CD4+CD25+Foxp3+ Regulatory T Cells in COPD

Respiratory Research — Fri, 28 Oct 2011 04:00:00 +0100

Conclusion: SFC can reduce the levels of inflammatory factors and improve symptoms of COPD. The levels of inflammatory factors are associated with the variation of Foxp3+Tregs in COPD.Trial registrationThis study was registered with chictr.org (Chinese Clinical Trial Register) as follows:ChiCTR-TNC-10001270 (Source: Respiratory Research)

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Salmeterol/fluticasone propionate: Cushing's syndrome: case report

Reactions — Wed, 12 Oct 2011 06:03:59 +0100

(Source: Reactions)

Inhaled corticosteroids versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.

Cochrane Database of Systematic Reviews — Tue, 11 Oct 2011 01:20:04 +0100

Acute Effects of Salmeterol and Fluticasone propionate Alone and in Combination on Airway Blood Flow in Subjects with Asthma.

Chest — Thu, 06 Oct 2011 04:00:00 +0100

CONCLUSIONS:The LABA salmeterol has an acute vasodilator action in the airway of subjects with stable asthma. The addition of fluticasone, which by itself causes vasoconstriction, does not attenuate the salmeterol-induced vasodilation, suggesting that fluticasone potentiates the vasodilator effect of salmeterol. The vasodilation could be of clinical benefit by promoting the vascular clearance of inflammatory mediators including spasmogens from the airway. Registered at Clinicaltrials.gov - NCT01231230 URL: clinicaltrials.gov. PMID: 21980058 [PubMed - as supplied by publisher] (Source: Chest)

Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: A randomized controlled study

Respiratory Medicine — Wed, 05 Oct 2011 04:00:00 +0100

Conclusion: Over the course of 24 weeks, FSC (250/50 μg twice daily) added to tiotropium provided greater improvement in lung function and quality of life in patients with COPD (FEV1 ≤ 65%) than tiotropium alone. (Source: Respiratory Medicine)

Combination Therapy Salmeterol/Fluticasone Versus Doubling Dose of Fluticasone in Children With Asthma

PEDIATRICS — Fri, 30 Sep 2011 04:00:00 +0100

(Source: PEDIATRICS)

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ADVAIR (Fluticasone Propionate And Salmeterol) Powder [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 14 Sep 2011 05:00:00 +0100

Updated Date: Sep 14, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Profiling the bronchodilator effects of the novel ultra-long-acting {beta}2-agonist indacaterol against established treatments in chronic obstructive pulmonary disease

Therapeutic Advances in Respiratory Disease — Wed, 07 Sep 2011 04:00:00 +0100

This article reviews the bronchodilator properties of indacaterol compared with other treatments used in COPD. Data from five published placebo-controlled studies were reviewed. Two 14-day crossover studies, the first comparing indacaterol 300 µg od with salmeterol 50 µg twice daily (bid), the second comparing indacaterol 150 µg and 300 µg od with tiotropium 18 µg od, assessed forced expiratory volume in 1 s (FEV1) at 24 h postdose (trough). Third, a 14-day crossover study evaluated trough FEV1 following indacaterol 300 µg dosed morning or evening compared with salmeterol 50 µg bid. Fourth, a single-dose study of indacaterol 150 and 300 µg measured FEV1 at 5 min postdose compared with salmeterol/fluticasone 50/500 µg and salbutamol 200 ...

Efficacy of a fixed combination of ciclesonide and formoterol: The EXCITED-study

Respiratory Medicine — Mon, 05 Sep 2011 04:00:00 +0100

Summary: Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The present study was designed to evaluate the efficacy of a newly developed fixed combination of ciclesonide and formoterol in comparison to the marketed fixed combination of fluticasone and salmeterol in patients with moderate asthma.This was a phase II, multi-centre, randomized, parallel-group, double-blind, double-dummy study. After a 2-week run-in period, 160 patients with moderate asthma were randomized to a 6-week treatment with ciclesonide/formoterol 320/9 μg bid (CIC/F) or fluticasone propionate/salmeterol 250/50 μg bid (FP/S), both delivered as powder formulations.The primary outcome FEV1 increased during treatment by 0.356 L in the CI...

ADVAIR HFA (Fluticasone Propionate And Salmeterol Xinafoate) Aerosol, Metered [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 01 Sep 2011 05:00:00 +0100

Updated Date: Sep 1, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

ADVAIR (Fluticasone Propionate And Salmeterol) Powder [Rebel Distributors Corp]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 22 Jul 2011 05:00:00 +0100

Updated Date: Jul 22, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Budesonide/Formoterol vs. Salmeterol/Fluticasone in COPDBudesonide/Formoterol vs. Salmeterol/Fluticasone in COPD

Medscape Today Headlines — Wed, 20 Jul 2011 11:04:28 +0100

This analysis looks at two widely-used combination inhalers for treatment of COPD. Is one product more likely to cause pneumonia than the other? International Journal of Clinical Practice (Source: Medscape Today Headlines)

Asthma control in patients receiving inhaled corticosteroid and long-acting beta2-agonist fixed combinations. A real-life study comparing dry powder inhalers and a pressurized metered dose inhaler extrafine formulation.

BMC Pulmonary Medicine - Latest articles — Thu, 14 Jul 2011 23:00:00 +0100

Conclusions: pMDI extrafine BDP/F combination demonstrated better asthma control compared to DPIs formulated with larger particles. This could be due to the improved lung deposition of the dose or less reliance on the optimal inhalation technique or both.Key words: inhaler, fixed combinations, asthma control, extrafine. (Source: BMC Pulmonary Medicine - Latest articles)

Systemic bioavailability of hydrofluoroalkane formulations containing fluticasone and salmeterol: a reply

British Journal of Clinical Pharmacology — Wed, 13 Jul 2011 16:44:23 +0100

(Source: British Journal of Clinical Pharmacology)

Systemic bioavailability of hydrofluoroalkane formulations containing fluticasone propionate and salmeterol

British Journal of Clinical Pharmacology — Wed, 13 Jul 2011 16:44:22 +0100

(Source: British Journal of Clinical Pharmacology)

Components of Asthma control and treatment response of individual control criteria in children: Analysis of the PEACE study

Pediatric Pulmonology — Thu, 30 Jun 2011 23:00:00 +0100

ConclusionDifferent outcomes improve at different rates. Assessment of one or a few outcomes over‐estimates the level of asthma control. An overall composite score in combination with the proportion of patients failing on three or more criteria seemed to most accurately reflect the level of control. Compared with SFC treatment, MON was three times less likely to result in good asthma control. Pediatr Pulmonol. © 2011 Wiley‐Liss, Inc. (Source: Pediatric Pulmonology)

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Systematic Review of the Safety of Regular Preventive Asthma Medications During Pregnancy (July/August).

The Annals of Pharmacotherapy — Mon, 27 Jun 2011 23:00:00 +0100

CONCLUSIONS Some negative outcomes of preventive asthma medications have been reported, although their direct link with medication use is inconclusive. Selection of preventive medications for asthma management during pregnancy should be based on an assessment of the risks and benefits of medication use versus the risks of poorly controlled asthma. PMID: 21712513 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD

Respiratory Medicine — Tue, 21 Jun 2011 23:00:00 +0100

Conclusion: FSC does not reduce aPWV in all patients with moderate to severe COPD, but may have effects in those with elevated arterial stiffness. Additional studies are required to determine if aPWV could serve as a surrogate for cardiovascular events in COPD. (Source: Respiratory Medicine)

Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials

International Journal of Clinical Practice — Thu, 16 Jun 2011 16:48:54 +0100

Conclusions: The results of the indirect comparison support the hypothesis that budesonide/formoterol is associated with fewer pneumonia events than salmeterol/fluticasone in chronic obstructive pulmonary disease. The limitations of the analysis are that the results from a single study, TORCH, have a large bearing on the overall findings of the analysis, and that there is heterogeneity in the length and the dosing of the included studies, although it does not appear that heterogeneity affected the reported results. Another important limitation is the lack of predefined diagnostic standards for pneumonia in these studies. (Source: International Journal of Clinical Practice)

Comparative Pulmonary Function and Pharmacokinetics of Fluticasone Propionate and Salmeterol Xinafoate Delivered by Two Dry Powder Inhalers to Patients with Asthma

Journal of Aerosol Medicine and Pulmonary Drug Delivery — Tue, 14 Jun 2011 17:05:30 +0100

Journal of Aerosol Medicine and Pulmonary Drug Delivery , Vol. 0, No. 0. (Source: Journal of Aerosol Medicine and Pulmonary Drug Delivery)

Glaxo Moves On New COPD Med Relovair As Advair Patent Expire Looms

Health News from Medical News Today — Thu, 02 Jun 2011 17:00:00 +0100

GlaxoSmithKline is already the asthma treatment industry leader with its Advair product and 2007 sales of US $6.9 billion. It will likely remain the market leader in the current generation of asthma medication, being a combination drug consisting of a corticosteroid and a long-acting beta antagonist. However, Advair's patent protection expires in both the United States and Europe in the next few years... (Source: Health News from Medical News Today)

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Fluticasone/salmeterol combination confers benefits in smoking asthmatics.

Chest — Wed, 01 Jun 2011 23:00:00 +0100

CONCLUSION: Fluticasone/salmeterol combination confers greater improvements in airway hyper-responsiveness and airway caliber in smoking asthmatics compared to double the dose of fluticasone. We hypothesize that in the presence of relative steroid resistance, the smooth muscle stabilization conferred by salmeterol is of greater clinical importance in smokers than in non-smokers. Trial Registration: ClinicalTrials.gov:NCT00830505. PMID: 21636667 [PubMed - as supplied by publisher] (Source: Chest)

Health status in the TORCH study of COPD: treatment efficacy and other determinants of change

Respiratory Research — Mon, 30 May 2011 23:00:00 +0100

Conclusions: In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.This study was funded by GlaxoSmithKline (study code SCO30003; www.clinicaltrials.gov registration number NCT00268216). (Source: Respiratory Research)

[clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics.]

Arerugi — Sun, 29 May 2011 23:00:00 +0100

Conclusion: The airway anti-inflammatory effect by 8 weeks maintenance therapy with fix-dosed FBC 640/18 μg/day (2 puffs twice a day) has been strongly suggested. PMID: 21617360 [PubMed - as supplied by publisher] (Source: Arerugi)

Clinical trials and tribulations: the MASCOT study

Thorax — Sun, 22 May 2011 23:00:00 +0100

Following the 1994 Lancet paper showing benefits of long-acting β-agonists (LABAs) in adults with asthma,1 British Paediatric Respiratory Society surveys have consistently recommended undertaking similar studies appropriately designed for children. Adult outcome measures should not be extrapolated into childhood, which explains why early studies indicated LABAs may be less helpful in children.2 With the advent of the Medicines for Children Research Network (MCRN) in 2004, the Health Technology Assessment (HTA) put out a call for children's medicines studies in 2005. The Management of Asthma in School Children On Therapy (MASCOT) study was funded in January 2006 pending Pharma approval to supply the medicines (fluticasone, fluticasone–salmeterol combination treatment and monteluk...

Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study

BMC Pulmonary Medicine - Latest articles — Sun, 22 May 2011 23:00:00 +0100

Conclusions: The results of this study indicate that fluticasone/formoterol is as effective as fluticasone/salmeterol, and has a more rapid onset of action, reflecting the faster bronchodilatory effects of formoterol compared with those of salmeterol. If patients perceive the benefits of therapy with fluticasone/formoterol more rapidly than with fluticasone/salmeterol, this could have a positive impact on preference and adherence.Clinicaltrials.gov identifier: NCT00476073 (Source: BMC Pulmonary Medicine - Latest articles)

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ADVAIR (Fluticasone Propionate And Salmeterol) Powder [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 19 May 2011 05:00:00 +0100

Updated Date: May 19, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

ADVAIR HFA (Fluticasone Propionate And Salmeterol Xinafoate) Aerosol, Metered [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 13 May 2011 05:00:00 +0100

Updated Date: May 13, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Mega trials in COPD - clinical data analysis and design issues.

Pneumonologia i Alergologia Polska — Thu, 05 May 2011 15:15:04 +0100

Authors: Suissa S, Ernst P The TORCH and UPLIFT randomised controlled trials have provided important data on the benefits of COPD treatments, but also some lessons in study design and data analysis that we will here review. Firstly, it is fundamental that the study question be answerable by the study design. The question in the TORCH study was aimed at a comparison with 'usual care', but the placebo group was not 'usual care'. Secondly, TORCH and UPLIFT were among the first trials to follow the intent-to-treat principle, fundamental to avoid bias in randomised trials. However, this principle was followed for the mortality outcome, but not for lung function, so that the findings related to lung function decline are subject to bias from regression to the mean. Finally, a re-analysis of t...

ADVAIR (Fluticasone Propionate And Salmeterol) Powder [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 26 Apr 2011 05:00:00 +0100

Updated Date: Apr 26, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

ADVAIR HFA (Fluticasone Propionate And Salmeterol Xinafoate) Aerosol, Metered [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 26 Apr 2011 05:00:00 +0100

Updated Date: Apr 26, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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COPD-related healthcare utilization and costs after discharge from a hospitalization or emergency department visit on a regimen of fluticasone propionate-salmeterol combination versus other maintenance therapies.

The American Journal of Managed Care — Sat, 23 Apr 2011 00:30:03 +0100

Authors: Dalal AA, Shah M, D'Souza AO, Mapel DW To quantify healthcare use and costs associated with chronic obstructive pulmonary disease (COPD) among patients discharged from a COPD-related hospitalization or emergency department (ED) visit on a regimen of fluticasone propionate-salmeterol combination versus other inhaled maintenance therapies. PMID: 21504260 [PubMed - in process] (Source: The American Journal of Managed Care)

Chronic Obstructive Pulmonary Disease Megatrials: Taking the Results into Office Practice.

The American Journal of the Medical Sciences — Tue, 19 Apr 2011 23:00:00 +0100

Authors: Stoloff SW Primary care specialists provide first-line care of chronic obstructive pulmonary disease (COPD), characterized by progressive, partially reversible airflow limitation induced mainly by smoking. Spirometry and questionnaires are important for COPD diagnosis, staging and prognosis. Smoking cessation, immunizations, pulmonary rehabilitation and self-management action plans comprise nonpharmacologic COPD management. The Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT®) and Towards a Revolution in COPD Health (TORCH) megatrials provide evidence for maintenance pharmacotherapy to reduce exacerbations and improve patient symptoms and health-related quality of life. Although the primary outcomes-lung function decline (UPLIFT®) and mortality ...

Long-term treatment with fluticasone propionate/salmeterol via Diskus improves asthma control versus fluticasone propionate alone

Allergy and Asthma Proceedings — Sat, 26 Mar 2011 14:57:41 +0100

(Source: Allergy and Asthma Proceedings)

Predictors of Pulmonary Function Response to Treatment with Salmeterol/fluticasone in Patients with Chronic Obstructive Pulmonary Disease.

J Korean Med Sci — Tue, 01 Mar 2011 00:00:00 +0100

Authors: Lee JS, Huh JW, Chae EJ, Seo JB, Ra SW, Lee JH, Kim EK, Lee YK, Kim TH, Kim WJ, Lee JH, Lee SM, Lee S, Lim SY, Shin TR, Yoon HI, Sheen SS, Oh YM, Lee SD Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and responses to therapies are highly variable. The aim of this study was to identify the predictors of pulmonary function response to 3 months of treatment with salmeterol/fluticasone in patients with COPD. A total of 127 patients with stable COPD from the Korean Obstructive Lung Disease (KOLD) Cohort, which were prospectively recruited from June 2005 to September 2009, were analyzed retrospectively. The prediction models for the FEV(1), FVC and IC/TLC changes after 3 months of treatment with salmeterol/fluticasone were constructed by using multiple, step...

Azathioprine-Induced Fever in Sarcoidosis (March).

The Annals of Pharmacotherapy — Tue, 22 Feb 2011 00:00:00 +0100

CONCLUSIONS: The rapid resolution of fever after discontinuation of azathioprine suggests that it was the likely source of fever in this patient. If azathioprine is increasingly prescribed in patients with sarcoidosis, fever as an adverse reaction may become more common. PMID: 21343403 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

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Comparison of high‐dose salmeterol/fluticasone and moderate‐dose salmeterol/fluticasone plus low‐dose mometasone in patients with severe persistent asthma

Respirology — Tue, 01 Feb 2011 00:00:00 +0100

Conclusions: In patients with severe persistent asthma, addition of low‐dose mometasone to SFC50/250 improved spirometric parameters, FENO, and PEF, while an increase in dose from SFC50/250 to SFC50/500 only improved PEF. (Source: Respirology)

Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers

European Journal of Clinical Pharmacology — Sat, 15 Jan 2011 07:08:54 +0100

Conclusions The breath-actuated SB device was comparable to ‘out of the box’ small and large volume spacers and produced similar improvements in relative systemic lung bioavailability for fluticasone and salmeterol. Content Type Journal ArticlePages 1-9DOI 10.1007/s00228-010-0989-9Authors Arun Nair, Asthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland DD1 9SYLorna McKinlay, Asthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland DD1 9SYPeter Williamson, Asthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland DD1 9SY...

ADVAIR (Fluticasone Propionate And Salmeterol) Powder [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 14 Jan 2011 05:00:00 +0100

Updated Date: Jan 14, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

ADVAIR HFA (Fluticasone Propionate And Salmeterol Xinafoate) Aerosol, Metered [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 14 Jan 2011 05:00:00 +0100

Updated Date: Jan 14, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

fluticasone and salmeterol oral inhaler, Advair Diskus

MedicineNet Medications General — Tue, 04 Jan 2011 07:00:00 +0100

Title: fluticasone and salmeterol oral inhaler, Advair DiskusCategory: MedicationsCreated: 1/22/2002 7:43:00 PMLast Editorial Review: 1/4/2011 (Source: MedicineNet Medications General)

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The production of 'aerodynamically equivalent' drug and excipient inhalable powders using a novel fractionation technique.

European Journal of Pharmaceutics and Biopharmaceutics — Thu, 23 Dec 2010 00:00:00 +0100

Authors: Taki M, Marriott C, Zeng XM, Martin GP Inhalation particles can be produced by various techniques such as milling, controlled crystallisation and spray-drying, but current methods cannot, to-date, precisely control the aerodynamic size distribution of produced powders. The aim of this study was to develop and validate a novel preparative technique whereby the efficient and reproducible aerodynamic fractionation of drug and excipient powders could be achieved. Salmeterol xinafoate (SX), fluticasone propionate (FP) and fine α-lactose monohydrate (FL) were chosen as model compounds. Powders were aerosolised using a dry powder feeder into a Next Generation Impactor operated at 60Lmin(-1). Powders deposited on NGI stages were then collected and analysed. The fractionation process ...

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Comparison of heat-sensitive moxibustion versus fluticasone/salmeterol (seretide) combination in the treatment of chronic persistent asthma: design of a multicenter randomized controlled trial

Trials — Wed, 15 Dec 2010 00:00:00 +0100

This study is comprised of a multi-centre (12 centers in China), randomized, controlled trial with two parallel arms (A: heat-sensitive moxibustion; B: conventional drug). Group A selects heat- sensitive acupoints from the rectangle region which consist of two outer lateral lines of dorsal Bladder Meridian of Foot-Taiyang, and two horizontal lines of BL13(Fei Shu) and BL17 (Ge Shu);6 inch outer the first and second rib gap of anterior chest. Group B treats with fluticasone/salmeterol (seretide). The outcome measures will be assessed over a 3-month period before each clinic visit at days 15, 30, 60, and 90. Follow-up visit will be at 3, 6 months after the last treatment session. Adverse event information will be collected at each clinic visit.DiscussionThis trial will utilize high quality t...

Outlook 2011, Part II: 2010 BioHealth Winners (AMRN, ILMN, INHX, JAZZ, NBIX, NPSP, THRX, VPHM)

BioHealth Investor — Tue, 30 Nov 2010 15:56:54 +0100

2011 is getting closer and closer, and we wanted to review some of the standout BioHealth winners for 2010 to see what their prospects are for 2011. The rounds of exponential gains seen in 2009 were not repeated as frequently in 2010 for the severity of gains. The FDA has been difficult to predict in 2010 and many companies with high expectations managed to become flops which either saw denied FDA approval or were given severe delays. We wanted to review the companies that are up more than 100% from their lows of the last 52-weeks to see which have prospects out into 2011 or beyond. Amarin Corporation plc (NASDAQ: AMRN), Illumina Inc. (NASDAQ: ILMN), Inhibitex Inc. (NASDAQ: INHX), Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ), Neurocrine Biosciences Inc. (NASDAQ: NBIX), NPS Pharmaceu...

SDI Reports: GlaxoSmithKline Sales Force No. 1 with Primary Care Physicians

Drugs.com - Pharma News — Tue, 30 Nov 2010 13:05:44 +0100

Maker of Advair Diskus, Lovaza and Avodart Jumps to First from Third in 2009 PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Nov 30, 2010 - According to SDI's 2010 Ranking Tables Study, office-based primary care physicians – general practitioners,... (Source: Drugs.com - Pharma News)

[a case of severe asthma responsive to omalizumab treatment despite a low serum ige level and lack of sensitized allergens.]

Arerugi — Tue, 30 Nov 2010 00:00:00 +0100

[A CASE OF SEVERE ASTHMA RESPONSIVE TO OMALIZUMAB TREATMENT DESPITE A LOW SERUM IGE LEVEL AND LACK OF SENSITIZED ALLERGENS.] Arerugi. 2010 Nov 30;59(11):1572-1579 Authors: Sugino Y, Sanda R, Takagi Y, Kato M, Ohta A, Okumura J, Nagai H A 49-year-old female patient suffering from severe intractable asthma uncontrolled even with high-dose inhaled glucocorticosteroids (fluticasone 1000 μg/day+ciclesonide 800 μg/day), salmeterol inhaler (100 μg/day) and oral betamethasone (1 mg/day) was admitted to our hospital because of severe asthma attack. The total serum IgE level was low at 9 (IU/mL). Though perennial allergens was also negative, administration of 150 mg omalizumab was started in August 2009 with the patient's consent, resulting in noticeable improvements in asthma symptom...

ADVAIR DISKUS (Fluticasone Propionate And Salmeterol) Powder [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 19 Nov 2010 05:00:00 +0100

Updated Date: Nov 19, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

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Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control.

Chest — Thu, 18 Nov 2010 00:00:00 +0100

CONCLUSIONS: In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equi-effective for most measures of asthma control. Study registration number: NCT00163358. PMID: 21088114 [PubMed - as supplied by publisher] (Source: Chest)

Combination therapy with the single inhaler salmeterol/fluticasone propionate versus increased doses of inhaled corticosteroids in patients with asthma

NeLM - Drug Class Focused Reviews — Wed, 20 Oct 2010 23:00:00 +0100

Source: DARE Area: Evidence > Drug Class Focused Reviews CRD Summary: The authors concluded that combination therapy with a single salmeterol and fluticasone inhaler improved lung function and symptoms in patients with asthma, compared to increased doses of inhaled corticosteroids. It did not significantly reduce the risk of exacerbation. Although few details were reported about trial quality, the review was otherwise well conducted and these conclusions appear likely to be reliable. CRD Commentary: The review objectives and inclusion criteria were clear. Relevant sources were searched for studies, although the restriction to articles in English may have created language bias. Steps were taken to minimise the risk of bias and error by having more than one reviewer independently extract ...

Lithera Announces Notice of Allowance for a Key Patent Application for LIPO-102, a Novel Treatment for Localized Fat Reduction

Medical News (via PRIMEZONE) — Tue, 12 Oct 2010 13:00:00 +0100

SAN DIEGO, Oct. 12, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application broadly covering compositions and methods of use associated with LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction. Once issued, this patent will afford the company market exclusivity for LIPO-102 into 2028. This news follows Lithera's recent announcement of positive results from a Phase II clinical trial of LIPO-102 showing dose- and time-related reductions in mean abdominal circumference and volume. (Source: Medical News (via PRIMEZONE))

Effect of addition of salmeterol versus doubling the dose of fluticasone propionate on specific airway resistance in children with asthma

Allergy and Asthma Proceedings — Thu, 07 Oct 2010 12:01:15 +0100

(Source: Allergy and Asthma Proceedings)

No Association of Catastrophic Events with Advair

The American Journal of Medicine — Thu, 30 Sep 2010 23:00:00 +0100

We respectfully disagree with conclusions reported by Salpeter et al, who state “that long-acting β-agonists carry significant risk for catastrophic asthma events, even when used concomitantly with inhaled corticosteroids.” (Source: The American Journal of Medicine)

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The Reply

The American Journal of Medicine — Thu, 30 Sep 2010 23:00:00 +0100

I understand the interest GlaxoSmithKline has in defending the safety of their product Advair, which is a single-inhaler combination of salmeterol and fluticasone. We found that long-acting β-agonists with inhaled corticosteroids increased catastrophic asthma events 3-fold compared with corticosteroids alone, with similar results seen for salmeterol and formoterol. Long-acting β-agonists significantly increased risk even when combined with inhaled corticosteroids in controlled double-blind fashion. (Source: The American Journal of Medicine)

Spiriva Improves Asthma Treatment

WebMD Health — Tue, 21 Sep 2010 05:00:00 +0100

Spiriva, a drug for severe lung disease, works at least as well as Advair for asthma patients who don't get relief from inhalers alone, an NIH-sponsored study finds. (Source: WebMD Health)

Salmeterol/fluticasone propionate: Perioral dermatitis: case report

Reactions — Wed, 08 Sep 2010 05:46:22 +0100

(Source: Reactions)

ADVAIR (Fluticasone Propionate And Salmeterol) Powder [Rebel Distributors Corp.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 08 Sep 2010 05:00:00 +0100

Updated Date: Sep 8, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Gender Differences in Mortality and Clinical Expressions of Patients with COPD: The TORCH Experience.

American Journal of Respiratory and Critical Care Medicine — Wed, 01 Sep 2010 23:00:00 +0100

CONCLUSION: Women enrolled in TORCH had a lower mortality rate than men but similar causes of death. The risk of dying was similar in women and men after adjusting for important baseline variables. Women reported more exacerbations, and worse dyspnea and health status scores than men. www.clinicaltrials.gov NCT00268216. PMID: 20813884 [PubMed - as supplied by publisher] (Source: American Journal of Respiratory and Critical Care Medicine)

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Randomized controlled trial of adherence with single or combination inhaled corticosteroid/long-acting β-agonist inhaler therapy in asthma

Journal of Allergy and Clinical Immunology — Tue, 31 Aug 2010 23:00:00 +0100

Conclusion: In the setting of a randomized controlled trial, use of a combination ICS/LABA inhaler does not markedly increase adherence above that observed with separate inhaler use. LABA monotherapy was observed in a small proportion of patients prescribed ICS and LABA therapy via separate inhalers. (Source: Journal of Allergy and Clinical Immunology)

Effects of adding salmeterol/fluticasone propionate to tiotropium on airway dimensions in patients with chronic obstructive pulmonary disease

Respirology — Tue, 31 Aug 2010 23:00:00 +0100

SUMMARY AT A GLANCE (Source: Respirology)

AARP Report Finds Increase In Brand-Name Drug Costs Outstrips Inflation

Health News from Medical News Today — Fri, 27 Aug 2010 11:00:00 +0100

AARP Bulletin: "Retail prices for some of the most widely used brand-name prescription drugs shot up more than 8 percent in 2009, even as inflation plummeted to a record low, according to a new AARP analysis of retail drug price trends released today. The AARP Rx Price Watch Report also looked at retail drug prices over the past five years and found some huge increases for popular drugs including the prostate drug Flomax, which nearly doubled in price; Advair and Aricept saw price hikes of 40 percent. During the same period, the consumer price index rose 13.3 percent... (Source: Health News from Medical News Today)

FDA issues warning on stolen Advair Diskus inhalers

Drug Topics - Clinical News — Thu, 12 Aug 2010 23:00:00 +0100

Certain lots of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhalers that were stolen from a GlaxoSmithKline (GSK) distribution warehouse near Richmond, Va., in August 2009 have recently been found in some pharmacies, according to FDA. (Source: Drug Topics - Clinical News)

Predictive factors for evaluation of response to fluticasone propionate/salmeterol combination in severe COPD

Respiratory Medicine — Thu, 12 Aug 2010 00:00:00 +0100

Summary: Background: The predictive factors for treatment response in patients with severe chronic obstructive pulmonary disease (COPD) are unknown. We investigated predictive factors for response to fluticasone propionate/salmeterol (FSC) in severe COPD patients.Methods: This prospective, open-label, non-comparative study included 921 adult patients with severe COPD (baseline forced expiratory volume in 1 s (FEV1) (Source: Respiratory Medicine)

GlaxoSmithKline Licenses Vectura Technology

BioHealth Investor — Mon, 09 Aug 2010 15:18:18 +0100

UK-based Vectura will be receiving $31.8 million, in addition to product royalties, from drug manufacturer GlaxoSmithKline for the rights to license Vectura’s dry powder drug formulation patents. The patents would allegedly be used for two late-stage drugs that are set by GSK to replace Advair, GSK’s asthma and COPD treatment, when it goes off-patent. These drugs are GSK642444 and GSK573719. Working to reassure shareholders, Vectura CEO stated in response to the deal that “the non-exclusive nature of this agreement also allows us to continue our efforts to deliver further value for shareholders from our inhaled therapy technologies in the future.” -Michael B. Sauter (Source: BioHealth Investor)

Cardiovascular events in patients with COPD: TORCH Study results

Thorax — Wed, 04 Aug 2010 09:01:41 +0100

Conclusion Post hoc analysis of the 3-year TORCH dataset showed that salmeterol alone or in combination (SFC) did not increase the risk of cardiovascular events in patients with moderate to severe COPD. (Source: Thorax)

Salmeterol/fluticasone in COPD not associated with increased cardiovascular event risk

NeLM - News — Tue, 03 Aug 2010 23:00:00 +0100

Source: Thorax Area: News Analysis of data from the TORCH study has not found any indication that treatment with inhaled salmeterol plus fluticasone for patients with chronic obstructive pulmonary disease (COPD) increases their risk of cardiovascular events. COPD is associated with an increase in cardiovascular risk, however it has also been suggested that treatment with some inhaled bronchodilator drugs may increase the risk further. This post hoc analysis of data from a prospective randomised controlled trial aimed to identify whether treatment with inhaled salmeterol plus fluticasone was associated with an increased risk of cardiovascular events. The TORCH trial was intended to investigate whether the drug combination reduced all-cause death in COPD: it did not show this, but ...

MeReC Monthly: Comparative safety of ICS/LABA combinations in chronic asthma

NeLM - News — Thu, 22 Jul 2010 23:00:00 +0100

This article from the National Prescribing Centre (NPC) discusses the findings of a Cochrane systematic review, which compared the safety of regular use of inhaled formoterol and salmeterol, both in combination with corticosteroid, in the treatment of asthma. The article notes that although no significant difference in terms of serious adverse events was found, such events were rare and there is therefore insufficient evidence to know for certain whether regular formoterol and budesonide (or formoterol and beclometasone) has an equivalent, or different, safety profile from salmeterol and fluticasone. There were little comparative safety data on formoterol and beclometasone (Fostair®), and no data available in children. Advice for healthcare professionals is giv...

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Stolen Advair Diskus inhalers not safe to use [News and Features]

AAP News — Mon, 19 Jul 2010 19:53:48 +0100

(Source: AAP News)

FDA Warns Of Stolen Inhalers' Safety

Drugs.com - Pharma News — Mon, 19 Jul 2010 13:07:25 +0100

From UPI Health News (Business) (July 16, 2010) Federal officials warned the U.S. public against using certain stolen Advair Diskus inhalers, saying their safety and effectiveness can’t be assured. Advair Diskus is an inhaler used to treat... (Source: Drugs.com - Pharma News)

FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers

MedlinePlus Health News — Mon, 19 Jul 2010 11:13:22 +0100

Source: Food and Drug Administration Related MedlinePlus Pages: Asthma, COPD (Chronic Obstructive Pulmonary Disease), Drug Safety (Source: MedlinePlus Health News)

FDA Warns Consumers, Pharmacists, And Wholesalers Not To Use Stolen Advair Diskus Inhalers

Health News from Medical News Today — Mon, 19 Jul 2010 08:00:00 +0100

The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhalerused to treat patients with asthma and chronic obstructive pulmonary disease. The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce... (Source: Health News from Medical News Today)

FDA Warns Public Regarding Stolen Advair Diskus Inhalers

Modern Medicine — Sun, 18 Jul 2010 23:00:00 +0100

The U.S. Food and Drug Administration issued a warning to consumers, pharmacists, and wholesalers that certain lots of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhalers were stolen from a GlaxoSmithKline distribution warehouse near Richmond, Virginia, in August 2009 and have recently been found in some pharmacies. (Source: Modern Medicine)

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FDA warns of stolen inhalers' safety

Health News - UPI.com — Fri, 16 Jul 2010 22:02:18 +0100

WASHINGTON, July 16 (UPI) -- Federal officials warned the U.S. public against using certain stolen Advair Diskus inhalers, saying their safety and effectiveness can't be assured. Fluticasone/salmeterol - Food and Drug Administration - Asthma - WASHINGTON - Australia (Source: Health News - UPI.com)

FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers

Drugs.com - Pharma News — Fri, 16 Jul 2010 19:07:36 +0100

SILVER SPRING, Md., July 16 /PRNewswire-USNewswire/ -- The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the... (Source: Drugs.com - Pharma News)

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

FDA MedWatch — Fri, 16 Jul 2010 18:10:00 +0100

Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. (Source: FDA MedWatch)

FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers

Food and Drug Administration — Fri, 16 Jul 2010 17:30:00 +0100

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

Drugs.com - FDA MedWatch Alerts — Fri, 16 Jul 2010 04:00:00 +0100

Audience: Pharmacy, Pulmonology, Patient ISSUE: Certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not... (Source: Drugs.com - FDA MedWatch Alerts)

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Primary Care Management of Chronic Obstructive Pulmonary Disease to Reduce Exacerbations and Their Consequences.

The American Journal of the Medical Sciences — Thu, 08 Jul 2010 23:00:00 +0100

Authors: Anzueto A Exacerbationsof chronic obstructive pulmonary disease (COPD)-acute worsenings of dyspnea, cough and/or sputum production beyond daily symptom variations, necessitating a change in treatment-account for most COPD-related morbidity, care burden and direct costs. Frequent exacerbations (especially those requiring emergency, inpatient or intensive care) reduce physical activity, accelerate lung function decline and increase mortality. This review profiles exacerbation diagnosis, treatment and reduction measures for primary care physicians. Chronic maintenance pharmacotherapy is important to reduce exacerbations. Tiotropium, a long-acting anticholinergic, and salmeterol/fluticasone, a long-acting beta-agonist/inhaled corticosteroid combination, are Food and Drug Administr...

Combination Therapy Salmeterol/Fluticasone versus Doubling Dose of Fluticasone in Children with Asthma.

American Journal of Respiratory and Critical Care Medicine — Thu, 08 Jul 2010 23:00:00 +0100

CONCLUSIONS: In our study the efficacy on symptom control and lung function of the combination of a long-acting bronchodilator with inhaled corticosteroid is equal to doubling the dose of the inhaled corticosteroid in children still symptomatic on a moderate dose of inhaled corticosteroid. Clinical Trials Registry Information: ID#NCT00197106 registered at www.clinicaltrials.gov. PMID: 20622031 [PubMed - as supplied by publisher] (Source: American Journal of Respiratory and Critical Care Medicine)

Relative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol in a 1-year, population-based, matched cohort study of patients with chronic obstructive pulmonary disease (COPD): Effect on COPD-related exacerbations, emergency department visits and hospitalizations, medication utilization, and treatment adherence.

Clinical Therapeutics — Wed, 30 Jun 2010 23:00:00 +0100

Conclusions: These COPD patients treated with BUD/FM were less likely to have ED visits and hospitalizations for COPD and used fewer doses of anticholinergic medication than patients treated with FP/SM in the year after treatment initiation. However, due to the observational nature of the study design, we cannot conclude with certainty that the medication was the only factor responsible for the observed differences. PMID: 20678680 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)

Salmeterol/fluticasone use yields savings in COPD

PharmacoEconomics and Outcomes News — Mon, 28 Jun 2010 07:09:38 +0100

(Source: PharmacoEconomics and Outcomes News)

FDA approves Merck asthma treatment to compete with Advair

bizjournals.com Health Care:Health Insurance headlines — Thu, 24 Jun 2010 13:57:21 +0100

A new inhaled asthma treatment from Merck & Co. has been approved by the U.S. Food and Drug Administration, bringing competition to GlaxoSmithKline’s Advair, which is manufactured in the Triangle. (MRK) (GSK) (MRK) (Source: bizjournals.com Health Care:Health Insurance headlines)

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Reported Pneumonia in COPD: Findings From the INSPIRE Study.

Chest — Wed, 23 Jun 2010 23:00:00 +0100

CONCLUSIONS: Pneumonia is much less frequent than exacerbation in COPD. The excess of events with ICS treatment appears to be associated with protracted symptomatic exacerbations. Earlier identification and treatment of these events to prevent pneumonia merits further investigation. PMID: 20576732 [PubMed - as supplied by publisher] (Source: Chest)

ADVAIR HFA (Fluticasone Propionate And Salmeterol Xinafoate) Aerosol, Metered [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 23 Jun 2010 05:00:00 +0100

Updated Date: Jun 23, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

ADVAIR (Fluticasone Propionate And Salmeterol) Powder [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 22 Jun 2010 05:00:00 +0100

Updated Date: Jun 22, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Stepping down to fluticasone propionate or a lower dose of fluticasone propionate/salmeterol combination in asthma patients recently initiating combination therapy

Allergy and Asthma Proceedings — Sat, 19 Jun 2010 05:02:11 +0100

(Source: Allergy and Asthma Proceedings)

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Adding salmeterol to fluticasone propionate or increasing the dose of fluticasone propionate in patients with asthma

Allergy and Asthma Proceedings — Sat, 19 Jun 2010 05:02:11 +0100

(Source: Allergy and Asthma Proceedings)

GSK Announces Revised Product Labels for Serevent and Advair

Drugs.com - Pharma News — Thu, 03 Jun 2010 14:04:52 +0100

RESEARCH TRIANGLE PARK, N.C., June 2 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:GSK) today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory... (Source: Drugs.com - Pharma News)

GSK announces revised product labels for Serevent and Advair

GSK news — Wed, 02 Jun 2010 16:30:00 +0100

GlaxoSmithKline [NYSE:GSK] today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent® and Advair®. (Source: GSK news)

Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children.

Annals of Allergy, Asthma and Immunology — Mon, 31 May 2010 23:00:00 +0100

CONCLUSIONS: Attenuation and response of EIB to albuterol rescue after exercise challenge were significantly better with montelukast than with salmeterol after 4 weeks of treatment. PMID: 20568384 [PubMed - in process] (Source: Annals of Allergy, Asthma and Immunology)

Advair blows off strong competition to remain first choice

PharmacoEconomics and Outcomes News — Mon, 17 May 2010 15:08:28 +0100

(Source: PharmacoEconomics and Outcomes News)

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Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary disease.

Cochrane Database of Systematic Reviews — Sun, 16 May 2010 06:39:04 +0100

CONCLUSIONS: Since the proportion of missing outcome data compared to the observed outcome data is enough to induce a clinically relevant bias in the intervention effect, the relative efficacy and safety of combined inhalers and tiotropium remains uncertain. Further large, long-term randomised controlled trials comparing combination therapy to tiotropium are required, including adequate follow-up of all participants randomised (similar to the procedures undertaken in TORCH and UPLIFT). Additional studies comparing alternative inhaled LABA/steroid combination therapies with tiotropium are also required. PMID: 20464758 [PubMed - in process] (Source: Cochrane Database of Systematic Reviews)

The effects of long-acting bronchodilators on total mortality in patients with stable chronic obstructive pulmonary disease

Respiratory Research — Mon, 10 May 2010 23:00:00 +0100

Conclusions: A combination of ICS and LABA reduced mortality by approximately 20%. Neither tiotropium nor LABA by itself modifies all-cause mortality in COPD. (Source: Respiratory Research)

Effect of salmeterol/fluticasone propionate combination on airway hyper-responsiveness in patients with well-controlled asthma

Respiratory Medicine — Sun, 09 May 2010 23:00:00 +0100

Summary: Background: The hypothesis that regular treatment aimed at achieving and maintaining asthma control is accompanied by reduced airway hyper-responsiveness (AHR) was investigated.Methods: Adult patients (PC20 methacholine (Source: Respiratory Medicine)

Lithera Reports Positive Clinical Study Results From a Second Phase IIa Trial for LIPO-102, a Novel Treatment for Localized Fat Reduction

Medical News (via PRIMEZONE) — Wed, 05 May 2010 13:00:00 +0100

SAN DIEGO, May 5, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced positive results from a Phase IIa clinical study of LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction. LIPO-102 was well-tolerated when administered weekly for 8 weeks into the subcutaneous abdominal fat of healthy subjects. LIPO-102 injections in the anterior abdomen produced dose- and time-related reductions in mean abdominal circumference and volume of -1.2 cm (versus -0.1 cm for placebo; p=0.048) and -183 cc (versus +24 cm for placebo; p=0.023), respectively, using 3-D photographic imaging. Consistent with the pharmacology of LIPO-102 and known changes in lipolytic sensitivity with age, younger and thinner patients demo...

Down-titration from high-dose combination therapy in asthma: Removal of long-acting β2-agonist

Respiratory Medicine — Thu, 29 Apr 2010 23:00:00 +0100

Conclusions: Many patients prescribed high-dose combination therapy may be over-treated. Substantial reductions in dose can be achieved with a clinical algorithm, reaching lower FP doses with SFC than FP without losing asthma control or increasing disease activity.Trial Registration: This study was commenced before mandatory registration of clinical trials. (Source: Respiratory Medicine)

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FDA finally admits that asthma drugs can actually cause serious asthma attacks

NaturalNews.com — Fri, 09 Apr 2010 07:00:00 +0100

(NaturalNews) The U.S. Food and Drug Administration (FDA) recently issued new restrictions for four popular long-acting asthma drugs. Novartis AG's Foradil, GlaxoSmithKline's Serevent and Advair, and AstraZeneca's Symbicort, all contain an ingredient that relaxes airway muscles in the lungs which can cause asthma-related death. If not accompanied by other asthma drugs to offset this life-threatening side effect, the consequences could be fatal.These drugs have long contained a label that reads, "increases risk of asthma-related death", but apparently this warning is not enough for this extreme class of medications. Known as long-acting beta-agonists (LABAs), these asthma drugs are used by roughly six million asthma sufferers to combat asthma symptoms. Ironically, LABAs are so dangerous tha...

Cost-effectiveness of Salmeterol/Fluticasone Combination Therapy vs. Fluticasone Propionate in Japanese Asthmatic Patients.

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan — Wed, 31 Mar 2010 23:00:00 +0100

Authors: Tohda Y, Nishima S, Arakawa I, Shiragami M, Miyamoto T We commenced to estimate the economic impact of salmeterol/fluticasone combination (SFC) therapy compared to fluticasone propionate (FP) therapy for asthma control in Japanese patients. A Markov model with five health states, developed by Price in 2002, was used. 1-week transition probabilities among status of asthma management were obtained from literature and epidemiological data from public data base. Direct cost for treatment was estimated from Japan medical fee schedule. Cost and effectiveness were not discounted due to 12-week simulation by the model. Univariate sensitivity analyses were undertaken to examine the main variables affecting cost-effectiveness. Probabilistic analysis was also undertaken to discuss statis...

Bias due to withdrawal in long-term randomised trials in COPD: Evidence from the TORCH study

The Clinical Respiratory Journal — Tue, 30 Mar 2010 23:00:00 +0100

Conclusion: Significant bias may occur in long-term RCTs of registered medications with symptomatic benefits as a result of differential withdrawal. Please cite this paper as: Vestbo J, Anderson JA, Calverley PMA, Celli B, Ferguson GT, Jenkins C, Yates JC, Jones PW. Bias due to withdrawal in long-term randomised trials in COPD: Evidence from the TORCH study. Clin Respir J 2010; DOI:10.1111/j.1752-699X.2010.00198.x. (Source: The Clinical Respiratory Journal)

Lithera Reports Positive Phase IIa Clinical Study Results for LIPO-102, a Novel Treatment for Localized Fat Reduction

Medical News (via PRIMEZONE) — Tue, 09 Mar 2010 14:00:00 +0100

SAN DIEGO, March 9, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced positive results from a Phase IIa clinical study of LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction. LIPO-102 is being studied for the treatment of exophthalmos using abdominal fat as a surrogate for periorbital fat. LIPO-102 was well-tolerated when administered weekly for 4 weeks into the subcutaneous abdominal fat of healthy subjects. Dose- and time-related reductions in abdominal circumference and skin-fold thickness measures were observed one (Week 5) and four (Week 8) weeks after the treatment period. A reduction of 3.47 cm (p=0.017) in mean abdominal circumference was observed at Week 8 in subjects receiving the o...

Controller medications and their effects on asthma exacerbations temporally associated with upper respiratory infections

Respiratory Medicine — Mon, 08 Mar 2010 00:00:00 +0100

Discussion: This retrospective analysis suggests that therapy with fluticasone propionate plus salmeterol provides protection against asthma exacerbations temporally associated with upper respiratory tract infections. This retrospective analysis supports the hypothesis that specific therapeutic approaches to mitigate virus-associated exacerbations may benefit asthma care. Well-controlled prospective studies are warranted. (Source: Respiratory Medicine)

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Leading Patient Education Organization To Asthma Patients: Talk To Your Healthcare Provider About FDA 12-Hour Bronchodilator Warnings

Health News from Medical News Today — Wed, 03 Mar 2010 11:00:00 +0100

Allergy & Asthma Network Mothers of Asthmatics (AANMA) encourages patients to make informed decisions about recent U.S. Food and Drug Administration (FDA) recommendations affecting patients using asthma medications known as long-acting beta agonists (LABAs) or 12-hour bronchodilators: Advair, Foradil, Serevent and Symbicort. This was also the message presented by allergists speaking this week at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in New Orleans... (Source: Health News from Medical News Today)

ADVAIR (Fluticasone Propionate And Salmeterol) Powder [Dispensing Solutions Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 03 Mar 2010 05:00:00 +0100

Updated Date: Mar 3, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Step-up therapy for children with asthma not controlled by inhaled corticosteroids

NeLM - News — Wed, 03 Mar 2010 00:00:00 +0100

Source: NEJM Area: News In a controlled trial, inhaled long-acting beta-agonist (LABA) was more likely than increased inhaled corticosteroid (ICS) dose or leukotriene antagonist to be effective as step-up treatment in children with asthma not controlled with ICS, however many children responded better to ICS or leukotriene antagonist. A significant proportion of children with asthma will not be controlled with low-dose ICS, however the evidence for the most effective step-up therapy is uncertain. This three-way crossover study was intended to determine whether inhaled LABA, increased ICS dose, or oral leukotriene antagonist would be most effective in such children. It involved children aged 6 to 17 years with mild to moderate asthma not adequately controlled on inhaled f...

NIH Study Looks At Long-Acting Asthma Drugs For Children

WSJ.com: Health — Tue, 02 Mar 2010 20:36:06 +0100

A study found that certain long-acting asthma drugs such as GlaxoSmithKline PLC's Advair were more likely to be the best add-on therapy for children whose asthma isn't well controlled by inhaled corticosteroids. (Source: WSJ.com: Health)

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Systemic bioavailability of hydrofluoroalkane (HFA) formulations of fluticasone/salmeterol in healthy volunteers via pMDI alone and spacer

British Journal of Clinical Pharmacology — Fri, 26 Feb 2010 00:00:00 +0100

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT [bull] Seretide (GlaxoSmithKline, UK) is a combination inhaler which contains both fluticasone (FP) and salmeterol (SM). [bull] A generic fluticasone/salmeterol (FP/SM) combination inhaler (Neolab, UK) has recently been developed. [bull] Determination of therapeutic equivalence is essential in the development of generic products. WHAT THIS STUDY ADDS [bull] This paper determines that in vitro fine particle dose may not predict pharmacokinetic and systemic pharmacodynamic outcomes. [bull] This paper shows that the generic and reference products were equivalent in terms of FP, but not SM pharmacokinetics. [bull] No significant differences were found between generic and reference products in terms of either adrenal suppression or hypokalaemia.AIM To co...

Leading Patient Education Group Provides Straight Answers To FDA's Announcement About Asthma Medications

Health News from Medical News Today — Wed, 24 Feb 2010 10:00:00 +0100

Allergy & Asthma Network Mothers of Asthmatics (AANMA) offered guidance to help patients understand recent Food and Drug Administration (FDA) warnings about Advair ® (fluticasone and salmeterol), Foradil ® (formoterol), Severent ® (salmeterol) and Symbicort ® (budesonide and formoterol), daily inhaled medications containing a long-acting beta agonist (LABA, a 12-hour bronchodilator). The FDA had two basic messages on Feb. 18: 1... (Source: Health News from Medical News Today)

Inhaled salmeterol and/or fluticasone alters structure/function in a murine model of allergic airways disease

BioMed Central — Wed, 24 Feb 2010 00:00:00 +0100

Conclusions: Fluticasone alone and in combination with salmeterol reduces airway inflammation and remodeling, but salmeterol alone worsens AHR: and these functional changes are consistent with the concomitant changes in mucus metaplasia. (Source: BioMed Central)

GSK Statement On FDA's Proposed Label Revisions For Some Asthma Medicines

Health News from Medical News Today — Sat, 20 Feb 2010 10:00:00 +0100

GlaxoSmithKline is reviewing label changes proposed by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted. "We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease," said Dr... (Source: Health News from Medical News Today)

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Glaxo rejects asthma drug claims

Pharmacy Europe — Fri, 19 Feb 2010 14:10:54 +0100

Pharmaceutical giant GlaxoSmithKline has said there is no evidence that its asthma drug Advair is linked with an increased risk of asthma-related death. (Source: Pharmacy Europe)

FDA calls for limits on asthma drugs

Los Angeles Times - Science — Fri, 19 Feb 2010 08:00:00 +0100

The agency's guidance affects Serevent, Advair, Symbicort and Foradil. Manufacturers will be required to include warnings on their labels. The Food and Drug Administration on Thursday called for putting new limits on powerful and long-lasting bronchial drugs that millions of Americans use to treat asthma -- a move designed to lower the risk of complications leading to hospitalization or even death. (Source: Los Angeles Times - Science)

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FDA Issues Warning on Key Asthma Drugs

Pharmacy News - Doctors Lounge — Thu, 18 Feb 2010 22:00:00 +0100

Advair, Foradil, Serevent and Symbicort should not be used alone due to safety concerns (Source: Pharmacy News - Doctors Lounge)

Tougher Labels for Asthma Drugs

WSJ.com: Health — Thu, 18 Feb 2010 18:32:29 +0100

The U.S. agency said it plans to implement new 'safety controls' for a class of long-acting asthma drugs, largely by adding tougher warnings about the proper use of the drugs to the product labels. The changes affect Glaxo's Advair and Serevent, Novartis's Foradil and AstraZeneca's Symbicort. (Source: WSJ.com: Health)

Triple therapy may benefit patients with severe COPD

MedWire News - Respiratory — Thu, 18 Feb 2010 00:00:00 +0100

Patients with severe chronic obstructive pulmonary disease who are undergoing pulmonary rehabilitation therapy and receiving salmeterol/fluticasone combination treatment may benefit from the addition of tiotropium, preliminary study findings suggest. (Source: MedWire News - Respiratory)

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Can low-dose combination products for inhalation be formulated in single crystalline particles?

European Journal of Pharmaceutical Sciences — Thu, 18 Feb 2010 00:00:00 +0100

In conclusion, co-spray dried particles of ICS/LABA/M-SD were largely crystalline, stable and showed excellent aerosol performance. They may provide an attractive alternative strategy to develop combination products without lactose blends. PMID: 20172026 [PubMed - as supplied by publisher] (Source: European Journal of Pharmaceutical Sciences)

Population Pharmacokinetics and Pharmacodynamics of Inhaled Ciclesonide and Fluticasone Propionate in Patients With Persistent Asthma.

The Journal of Clinical Pharmacology — Thu, 11 Feb 2010 00:00:00 +0100

The objectives of this study were to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of FP and a pharmacologically active metabolite of CIC (desisobutyrylciclesonide [Des-CIC]) using a nonlinear mixed-effects modeling approach, to investigate selected covariate effects on PK and PD parameters of FP and Des-CIC, and to assess the systemic effects of FP and CIC on serum cortisol suppression in patients with persistent asthma. This was a randomized, double-blind, placebo-controlled, double-dummy, 5-period, crossover, multicenter clinical study. A total of 32 patients were enrolled and given basic asthma medication (salmeterol 50 mug twice per day [BID] and CIC 160 mug daily in the evening) through the entire study. During crossover periods, patients were given placebo or CIC 160 ...

Lithera Successfully Completes Phase I Clinical Trial of LIPO-102

Medical News (via PRIMEZONE) — Tue, 09 Feb 2010 14:00:00 +0100

SAN DIEGO, Feb. 9, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced the successful completion of a three-part Phase I clinical trial of LIPO-102 being developed for the treatment of thyroid-related (Graves' Disease) exophthalmos. LIPO-102 is a novel, minimally-invasive, non-ablative approach to localized fat reduction comprising an injectable aqueous combination of salmeterol xinafoate (SX) and fluticasone propionate (FP). This Phase I clinical study, carried out in abdominal adipose tissue serving as a surrogate for orbital adipose tissue, established the safety and pharmacokinetics of LIPO-102 at maximal doses within the 505(b)(2) threshold for a previously FDA-registered drug product. This trial also provided preliminary evidence of efficacy showing dose-related reductions in wais...

Children do best on fluticasone propionate + salmeterol

PharmacoEconomics and Outcomes News — Mon, 08 Feb 2010 16:10:21 +0100

(Source: PharmacoEconomics and Outcomes News)

Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis

Allergy and Asthma Proceedings — Fri, 05 Feb 2010 13:38:48 +0100

(Source: Allergy and Asthma Proceedings)

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Kaletra (Lopinavir/Ritonavir) Product Label Updated to Revise Drug-Drug Interactions

Fri, 05 Feb 2010 00:00:00 +0100

“On January 29, 2009, FDA approved revisions to the Kaletra (lopinavir/ritonavir) package insert to include drug-drug interaction information for concurrent Kaletra administration with inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair) and sildenafil (Revatio). “Specifically, sildenafil (Revatio) when used for the treatment of pulmonary arterial hypertension is listed under Contraindications … because a safe and effective dose has not been established when used with Kaletra. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erections and syncope. … “Concurrent administration of salmeterol and Kaletra is not recommended. The combination may...

The effect of inhaled salmeterol, alone and in combination with fluticasone propionate, on management of COPD patients

The Clinical Respiratory Journal — Thu, 04 Feb 2010 00:00:00 +0100

Conclusions: These results indicated that inhaled corticosteroids may be beneficial in some patients with COPD. Please cite this paper as: Mansori F, Nemat Khorasani A, Boskabady MH and Boskabady M. The effect of inhaled salmeterol, alone and in combination with fluticasone propionate, on management of COPD patients. Clin Respir J 2010; DOI:10.1111/j.1752-699X.2010.00185.x. (Source: The Clinical Respiratory Journal)

ADVAIR HFA (Fluticasone Propionate And Salmeterol Xinafoate) Aerosol, Metered [GlaxoSmithKline LLC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 02 Feb 2010 05:00:00 +0100

Updated Date: Feb 2, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma

Allergy — Thu, 28 Jan 2010 00:00:00 +0100

Conclusion: The findings of this pilot study suggest that an extra-fine inhaled combination for the treatment of asthma has beneficial effects on both large and small airways function as expressed by Mch and sbN2 tests. (Source: Allergy)

Asthma in adults

Clinical Evidence — Thu, 21 Jan 2010 23:00:00 +0100

New evidence; conclusions changed for: Education about acute asthma One systematic review (search date 2006) added comparing education versus usual care in adults who had attended an emergency department for asthma exacerbation. It found that education reduced hospital admissions compared with usual care, but it found no significant difference in subsequent presentations to emergency departments, primary care physician urgent visits, primary care physician call outs, quality of life, physical limitations caused by asthma, or lung function, between education and control. Evidence added at update does not support evidence previously reported on effects of education about asthma. Considering evidence added at update, categorisation changed from "Beneficial" to "Unkno...

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Long acting beta2-agonist and corticosteroid restore airway glandular cell function altered by bacterial supernatant

BioMed Central — Wed, 20 Jan 2010 00:00:00 +0100

Conclusions: Our results demonstrate that treatment with the combination of a corticosteroid and a long-acting beta2 adrenergic receptor agonist after bacterial infection restores the airway glandular cell function. Abnormal mucus induced by defective ion transport during pulmonary infection could benefit from treatment with a combination of beta2-AR agonist and corticosteroid. (Source: BioMed Central)

Osteoporosis common in COPD patients but unaffected by medium-term inhaled corticosteroid

NeLM - News — Tue, 05 Jan 2010 00:00:00 +0100

Source: CHEST Area: News Analysis of data from the TORCH study found a high rate of osteoporosis in patients with chronic obstructive pulmonary disease (COPD), however treatment with inhaled corticosteroid (ICS) did not affect incidence over a three-year period. There is some concern over the potential adverse effects of ICS on bone health in patients with COPD: the randomised, double-blind, placebo-controlled TORCH study involved COPD patients treated with ICS (fluticasone), a long-acting beta-agonist (salmeterol) and the two in combination for three years. This paper reports analysis of bone health in a subset of patients included in the study. As part of the study design, bone mineral density (BMD) for the hip and lumbar spine was obtained at baseline and yearly thereafter. ...

Summertime Use of Combo Inhaler May Reduce Asthma Events in the Fall

Medscape Medical News Headlines — Mon, 04 Jan 2010 17:20:22 +0100

Summertime use of fluticasone propionate and salmeterol (FSC) in a single inhaler protects against serious asthma-related exacerbations in the fall, a new study suggests. Reuters Health Information (Source: Medscape Medical News Headlines)

Meta-analysis of the risk of mortality with salmeterol and the effect of concomitant inhaled corticosteroid therapy

Thorax — Tue, 22 Dec 2009 21:43:22 +0100

Conclusions: Salmeterol monotherapy in asthma increases the risk of asthma mortality and this risk is reduced with concomitant ICS therapy. There is no evidence that combination salmeterol/fluticasone propionate therapy is associated with an increased risk of asthma mortality, although this interpretation is limited by the low statistical power of available studies. (Source: Thorax)