Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Summary

The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Timeline

Start

2009-10-19

Primary completion

2011-02-01

Completion

2011-02-08

Outcome

Met primary endpoint

registry Placebo vs FF/VI 100/25 µg OD; p <0.001; Least squares mean difference 0.214 (95% CI 0.161 to 0.266) NCT01054885 ↗

registry Placebo vs FF/VI 200/25 µg OD; p <0.001; Least squares mean difference 0.209 (95% CI 0.157 to 0.261) NCT01054885 ↗

registry Placebo vs FF/VI 100/25 µg OD; p <0.001; Least squares mean difference 0.144 (95% CI 0.091 to 0.197) NCT01054885 ↗

registry Placebo vs FF/VI 200/25 µg OD; p <0.001; Least squares mean difference 0.131 (95% CI 0.080 to 0.183) NCT01054885 ↗

Publications

• Background Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, Crim C, Calverley PM. Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in COPD: a randomised trial. Respir Med. 2013 Apr;107(4):550-9. doi: 10.1016/j.rmed.2012.12.016. Epub 2013 Jan 16.
• Yang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70059. doi: 10.1002/psp4.70059. Epub 2025 Jun 19.
• Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone Furoate	Other / unclassified	—	Inhaled
Subject	Vilanterol	Other / unclassified	—	Inhaled

Indications