Clinical trial NCT02094937
Conditions: Asthma
Keywords: fluticasone propionate step-down regimen well-controlled subjects adults switching regimen asthma fluticasone furoate fluticasone furoate/Vilanterol
Sponsor: GlaxoSmithKline
Start date: 2014-03-27; Completion date: 2015-08-28
Enrollment: 430 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25 micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1 (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well controlled asthma after completing a run-in period of 4 weeks will be switched from middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25 mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a 1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week Follow-up Period following completion of the double-blind treatment period, or early withdrawal from the study. Overall , the total duration of subject's participation in the study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.

Detailed description:

Arms: arm 1: Subjects will receive Fluticasone Furoate/Vilanterol 100/25 mcg once-daily via a dry powder inhaler for 8 weeks in the open-label treatment period. arm 2: Subjects will receive Fluticasone Propionate matching placebo twice-daily (morning and evening) and Fluticasone Furoate 100 mcg once daily in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period arm 3: Subjects will receive Fluticasone Propionate 250 mcg twice-daily (morning and evening) and Fluticasone Furoate matching placebo once daily in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period arm 4: Subjects will receive Fluticasone Propionate 100 mcg twice-daily (morning and evening) and Fluticasone Furoate matching placebo once daily in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period
Interventions: intervention 1: Fluticasone Furoate/Vilanterol intervention 2: Fluticasone Furoate 100 mcg intervention 3: Fluticasone Propionate 250 mcg intervention 4: Fluticasone Propionate 100 mcg intervention 5: Fluticasone Furoate Placebo intervention 6: Fluticasone Propionate Placebo
Intervention descriptions: intervention 1: FF/VI 100mg/25 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler intervention 2: FF 100 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler intervention 3: FP 250 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler intervention 4: FP 100 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler intervention 5: Matching placebo of Fluticasone Furoate will be given once daily in the evening via dry powder inhaler intervention 6: Matching placebo of Fluticasone Propionate will be given twice daily (morning and evening) via dry powder inhaler

Protocol documents: