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

2008-10-01

Completion

2008-10-02

Outcome

Met primary endpoint

registry Placebo vs GW685698X 50 µg OD; p = 0.033; Mean Difference (Final Values) 0.129 (95% CI 0.011 to 0.247); ANCOVA NCT00603382 ↗

registry Placebo vs GW685698X 100 µg OD; p <0.001; Median Difference (Final Values) 0.204 (95% CI 0.089 to 0.319); ANCOVA NCT00603382 ↗

Publications

• Background Bateman ED, Bleecker ER, Lotvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012 May;106(5):642-50. doi: 10.1016/j.rmed.2012.01.004. Epub 2012 Feb 18.
• Background Psaila B, Bussel JB, Linden MD, Babula B, Li Y, Barnard MR, Tate C, Mathur K, Frelinger AL, Michelson AD. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012 Apr 26;119(17):4066-72. doi: 10.1182/blood-2011-11-393900. Epub 2012 Jan 31.
• 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