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Proposal 611

Title of the Proposed Research

Long-acting beta2-agonists for chronic obstructive pulmonary disease

Lead Researcher

Kayleigh Kew

Affiliation

Cochrane Airways Group, at St George's University of London
London, UK

Data Sharing Agreement Date

31 October 2013

Lay Summary

LABAs are used widely and play a central role in the management of COPD. An earlier Cochrane systematic review has presented the evidence on the effects of LABAs for patients with poorly reversible COPD. However, in this systematic review we will summarise the evidence regarding the efficacy and safety of LABAs with a 12-hour duration of action compared with placebo in all patients with COPD.

Aim:  To assess the effects of long-acting beta2-agonists compared with placebo for patients with chronic obstructive pulmonary disease (COPD), upon clinically-important endpoints

Methods:  We will include randomised controlled trials (RCTs) with a parallel group design, of at least 12 weeks duration. We will not exclude studies on the basis of blinding. We will exclude cross-over trials as we are looking at long-term effects including adverse events. We will include RCTs which recruited patients with a clinical diagnosis of COPD. We will include studies in which participants were randomised to receive: salmeterol 50 µg or placebo twice daily; formoterol 12 µg or placebo twice daily; formoterol 24 µg or placebo twice daily. We will include studies which allow concomitant short-acting bronchodilators, provided they are not part of the trial treatment under study. We will not include studies in which a majority of the participants are on other COPD treatments. We are interested in the following outcomes: quality of life, severe and moderate COPD exacerbations, mortality, serious adverse events, trough FEV1 and withdrawals. We will conduct comprehensive literature searches and clinicaltrials.gov for relevant RCTs. Two review authors will identify trials, extract data and assess studies for risk of bias. Dichotomous data will be analysed using Mantel-Haenzsel odds ratios and continuous data will be analysed as fixed effects mean differences in the Cochrane Review Manager (RevMan software). Heterogeneity will be explored with the I squared statistic. For all outcomes we will analyse each LABA and dose separately, however for our primary outcomes we will also pool the three comparisons.

Findings will be interpreted and written up by at least two authors, with relevant clinical guidance. The review will be published in the Cochrane Library of Systematic Reviews.

Study Data Provided

Study SFCB3024: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of the salmeterol/FP combination product at a strength of 50/500mcg bd with salmeterol 50mcg bd alone and FP 500mcg bd alone, delivered via the DISKUS™/ACCUHALER™, in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 12 months
Study SCO30003: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (Seretide tm) 50/500mcg BD, salmeterol 50mcg BD and fluticasone propionate 500mcg BD, all delivered via the Diskus tm/Accuhaler tm inhaler, on mortality and morbidity of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment
Study SFCA3007: A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulation of salmeterol 50mcg BID and fluticasone propionate 250mcg BID individually and in combination as compared to placebo in COPD patients
Study SLGA4005: A Randomized, Double-Blind, Double-Dummy, Comparative Clinical Trial of 12-Week Courses of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Placebo (PRN Ventolin®) in Subjects With Chronic Obstructive Pulmonary Disease
Study SFCA3006: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Evaluating the Safety and Efficacy of the DISKUS Formulations of Salmeterol (SAL) 50mcg BID and Fluticasone Propionate (FP) 500mcg BID Individually and in Combination as Salmeterol 50mcg/Fluticasone Propionate 500mcg BID (SFC 50/500) Compared to Placebo in COPD Subjects
Study SLGA4004: A Randomized, Double-blind, Double-Dummy, Comparative Clinical Trial of 12-Week Courses of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Placebo (PRN Ventolin) in Subjects With Chronic Obstructive Pulmonary Disease
Study FLTA3025: A Randomized, Double-Blind, Double-Dummy, Comparative Clinical Trial of 12-Week Courses of Salmeterol Xinafoate Versus Ipratropium Bromide Versus Placebo (PRN Ventolin®) in Subjects With Chronic Obstructive Pulmonary Disease
Study SCO100470: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Study FCO30002: German study: “A multicentre, randomised, placebo-controlled, double-blind comparison with 3 parallel groups to investigate the efficacy and safety of inhaled glucocorticoid Fluticasone (500 μg bd via Diskus™) vs. oral glucocorticoid therapy vs. placebo in subjects with chronic obstructive airway disease (COPD) under therapy with Salmeterol (50 μg bd)

Note: Datasets from this local German study are not available. Following a local legal review of the informed consent form which was used in study we have been advised that, under German law, we are not allowed to anonymise the relevant datasets for this specific study as we did not at the time seek consent for the process of anonymisation.
Study SCO30002: Italian study: “A Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Compare the Efficacy and Safety of Inhaled Salmeterol/Fluticasone Propionate Combination Product 25/250 μg Two Puffs Bd and Fluticasone Propionate 250μg Two Puffs Bd Alone, All Administered Via Metered Dose Inhalers (MDI), in the Treatment of Subjects with Chronic Obstructive Pulmonary Disease (COPD) for 52 Weeks
Study SLMF4010: French study “Multicentre, randomised, parallel group, placebo-controlled, double-blind, study, stratified on tobacco status at enrollment, evaluating during 6 months the efficacy of salmeterol powder for inhalation, 50 µg two times per day for the reduction of thoracic distension in subjects with chronic obstructive disease (COPD)

Funding Source of Research

NIHR Program Grant to fund a reviewer at the Cochrane Airways Group

Potential Conflicts of Interest

None

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation