Long-acting beta2-agonists for chronic obstructive pulmonary disease

Long-acting beta2-agonists for chronic obstructive pulmonary disease

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

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 endpointsMethods: 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.

[{ "PostingID": 393, "Title": "GSK-FCO30002", "Description": "Medicine: fluticasone propionate, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 4, GSK Clinical Study ID: FCO30002, Sponsor: GSK ." },{ "PostingID": 394, "Title": "GSK-FLTA3025", "Description": "A randomized, double-blind, parallel-group, comparative trial of inhaled fluticasone propionate 250mcg twice daily, 500mcg twice daily, and placebo twice daily via the DISKUS® inhaler in subjects with chronic obstructive pulmonary disease (COPD).

Medicine: fluticasone propionate, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: FLTA3025, Sponsor: GSK" },{ "PostingID": 416, "Title": "GSK-SCO30003", "Description": "A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE® inhaler) 50/500mcg BD, salmeterol 50mcg BD and fluticasone propionate 500mcg BD, all delivered via the DISKUS®/ACCUHALER® inhaler, on mortality and morbidity of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment

Medicine: fluticasone propionate/salmeterol, Condition: Pulmonary Disease, Chronic Obstructive," },{ "PostingID": 425, "Title": "GSK-SFCB3024", "Description": "A multicentre, randomised, double-blind, parallel group study to compare the efficacy and safety of the Salmeterol/Fluticasone combination product (50/500mg strength) twice daily with Salmeterol 50mg twice daily alone and Fluticasone Propionate 500mg twice daily alone, all delivered via the Diskus/Accuhaler inhaler, in the treatment of patients with chronic obstructive pulmonary disease.

Medicine: fluticasone propionate/salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Stu" },{ "PostingID": 426, "Title": "GSK-SFCA3007", "Description": "A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulation of salmeterol 50mcg twice daily and fluticasone propionate 250mcg twice daily individually and in combination as compared to placebo in COPD patients.

Medicine: fluticasone propionate/salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: SFCA3007, Sponsor: GSK" },{ "PostingID": 427, "Title": "GSK-SFCA3006", "Description": "A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulations of salmeterol 50mcg twice daily and fluticasone propionate 500mcg twice daily individually and in combination as compared to placebo in COPD patients.

Medicine: fluticasone propionate/salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: SFCA3006, Sponsor: GSK" },{ "PostingID": 428, "Title": "GSK-SCO100470", "Description": "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).

Medicine: fluticasone propionate/salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: SCO100470, Sponsor: GSK" },{ "PostingID": 429, "Title": "GSK-SCO30002", "Description": "A multicentre randomised double-blind parallel group placebo controlled study assessing the efficacy and safety of inhaled salmeterol/fluticasone 50/500mcg twice daily, inhaled fluticasone 500mcg twice daily and placebo all administered via MDI in the treatment of patients with COPD

Medicine: fluticasone propionate/salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: SCO30002, Sponsor: GSK" },{ "PostingID": 511, "Title": "GSK-SLGA4005", "Description": "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

Medicine: salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: SLGA4005, Sponsor: GSK" },{ "PostingID": 512, "Title": "GSK-SLGA4004", "Description": "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

Medicine: salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: SLGA4004, Sponsor: GSK" },{ "PostingID": 513, "Title": "GSK-SLMF4010", "Description": "Medicine: salmeterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 4, GSK Clinical Study ID: SLMF4010, Sponsor: GSK ." }]

The publication citation will be added after the research is published.