A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy.

Summary

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Timeline

Start

2007-12-01

Primary completion

2008-09-01

Completion

2008-09-20

Outcome

Met primary endpoint

registry Placebo vs GW685698X 200 µg OD; p <0.001; Median Difference (Final Values) 0.275 (95% CI 0.180 to 0.370); ANCOVA NCT00603746 ↗

registry Placebo vs GW685698X 400 µg OD; p <0.001; Median Difference (Final Values) 0.272 (95% CI 0.178 to 0.367); ANCOVA NCT00603746 ↗

registry Placebo vs GW685698X 600 µg OD; p <0.001; Median Difference (Final Values) 0.264 (95% CI 0.171 to 0.357); ANCOVA NCT00603746 ↗

registry Placebo vs GW685698X 800 µg OD; p <0.001; Mean Difference (Final Values) 0.225 (95% CI 0.131 to 0.320); ANCOVA NCT00603746 ↗

Publications

• Background Busse WW, Bleecker ER, Bateman ED, Lotvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012 Jan;67(1):35-41. doi: 10.1136/thoraxjnl-2011-200308. Epub 2011 Aug 9.
• O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.

Drugs

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

Indications