A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-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

Primary completion

2008-11

Completion

2008-11

Outcome

Met primary endpoint

registry Placebo vs GW685698X 100 µg OD; p <0.001; Mean Difference (Final Values) 0.207 (95% CI 0.096 to 0.318); ANCOVA NCT00603278 ↗

registry Placebo vs GW685698X 200 µg OD; p <0.001; Mean Difference (Final Values) 0.238 (95% CI 0.127 to 0.349); ANCOVA NCT00603278 ↗

registry Placebo vs GW685698X 300 µg OD; p <0.001; Mean Difference (Final Values) 0.293 (95% CI 0.182 to 0.404); ANCOVA NCT00603278 ↗

registry Placebo vs GW685698X 400 µg OD; p <0.001; Mean Difference (Final Values) 0.279 (95% CI 0.167 to 0.392); ANCOVA NCT00603278 ↗

Publications

• Background Bleecker ER, Bateman ED, Busse WW, Woodcock A, Frith L, House KW, Jacques L, Davis AM, Haumann B, Lotvall J. Once-daily fluticasone furoate is efficacious in patients with symptomatic asthma on low-dose inhaled corticosteroids. Ann Allergy Asthma Immunol. 2012 Nov;109(5):353-358.e4. doi: 10.1016/j.anai.2012.08.017.
• 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.
• Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

Drugs

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

Indications