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

Summary

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

Timeline

Start

2009-09-25

Primary completion

2011-10-01

Completion

2011-10-31

Outcome

Mixed primary results

registry VI 25 µg QD vs FF/VI 100/25 µg QD; p <0.001; Risk Ratio (RR) 0.66 (95% CI 0.54 to 0.81) NCT01009463 ↗

registry VI 25 µg QD vs FF/VI 50/25 µg QD; p = 0.181; Risk Ratio (RR) 0.87 (95% CI 0.72 to 1.06) NCT01009463 ↗

registry VI 25 µg QD vs FF/VI 200/25 µg QD; p = 0.109; Risk Ratio (RR) 0.85 (95% CI 0.70 to 1.04) NCT01009463 ↗

Publications

• Background Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12.
• Largajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.
• Hinds DR, DiSantostefano RL, Le HV, Pascoe S. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open. 2016 Jun 1;6(6):e010099. doi: 10.1136/bmjopen-2015-010099.
• Crim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Lettis S, Calverley PM. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27-34. doi: 10.1513/AnnalsATS.201409-413OC.
• 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	50 ug	—
Subject	Fluticasone Furoate	Other / unclassified	100 ug	—
Subject	Fluticasone Furoate	Other / unclassified	200 ug	—
Subject	Vilanterol	Other / unclassified	25 ug	Inhaled

Indications