An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (Mcg) FF/VI 100/25 Mcg and FF 100 Mcg in Adults and Adolescents With Persistent Asthma.
This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study
with three active comparators in subjects with moderate to severe persistent asthma. The
study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks,
and a follow up contact period of one week. The total duration of the study is 17 weeks. 990
subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg
once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF
100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects
will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for
acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment
visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).
Clinical Trial Conditions: Asthma
Treatments in this Clinical Trial : Fluticasone Furoate/ Vilanterol 200/25 mcg, Fluticasone Furoate/ Vilanterol 100/25 mcg, Fluticasone Furoate 100 mcg
Clinical Trial Phase: Phase 3
Eligible Clinical Trial Participant Age : Between 12 years to 100 years
Can Healthy Volunteers Participate: No
Clinical Trial Lead Sponsor: GlaxoSmithKline
Detailed Clinical Trial Description: This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study
with three active comparators in subjects with moderate to severe persistent asthma. The
study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks,
and a follow up contact period of one week. The total duration of the study is 17 weeks. 990
subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg
once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF
100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects
will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for
acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment
visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).
The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01686633
