Efficacy and safety of fluticasone furoate 100 mug and 200 mug once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study

This study was performed to descriptively assess the efficacy and safety of two doses of FF, with no planned formal statistical hypothesis testing. Methods: This was a 24-week double-blind, multicentre, parallel-group study (NCT01431950). Patients aged >=12 years with moderate-severe persistent asthma and uncontrolled on mid-high dose ICS were stratified by baseline FEV1 and randomised (1:1) to treatment with FF 100mug or 200mug once daily in the evening. The primary endpoint was change from baseline trough FEV1 after 24 weeks; secondary and other endpoints included peak expiratory flow (PEF) and rescue- and symptom-free 24-hour periods over Weeks 1-24, and Asthma Control TestTM (ACT) score at Week 24. A pre-specified subgroup analysis of patients by randomisation strata was performed for the primary and selected secondary and other endpoints. Safety assessments included adverse events, laboratory and vital sign measurements, and change from baseline in 24-hour urinary cortisol at Week 24. Results: With FF 100mug and 200mug, least squares mean trough FEV1 improved from baseline by 208mL and 284mL respectively at Week 24; treatment difference: 77mL (95% CI: -39, 192). Similar improvements from baseline in rescue- and symptom-free periods, and morning and evening PEF were observed in both groups. Patients were 42% more likely to be well-controlled (ACT score >=20) with FF 200mug than with FF 100mug. Slightly more patients receiving FF 200mug vs. FF 100mug reported adverse event...
Source: BMC Pulmonary Medicine - Latest articles - Category: Respiratory Medicine Authors: Source Type: research