Conditions: Asthma
Keywords: asthma pharmacogenetics adult vilanterol adolescents fluticasone furoate
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 1040
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (\<=65% or \>65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 200/25 mcg once daily in the evening for 84 days. arm 2: At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (\<=65% or \>65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 100/25 mcg once daily in the evening for 84 days arm 3: At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (\<=65% or \>65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF 100 mcg once daily in the evening for 84 days

Interventions: intervention 1: Fluticasone Furoate/ Vilanterol 200/25 mcg intervention 2: Fluticasone Furoate/ Vilanterol 100/25 mcg intervention 3: Fluticasone Furoate 100 mcg
Intervention descriptions: intervention 1: Fluticasone furoate/ vilanterol will be available as 200/25 mcg Novel dry powder inhaler (NDPI) with 30 doses per device and 200/25 mcg per actuation intervention 2: Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation intervention 3: Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

Protocol document: