PMID- 22796247 OWN - NLM STAT- MEDLINE DCOM- 20121228 LR - 20131121 IS - 1879-114X (Electronic) IS - 0149-2918 (Linking) VI - 34 IP - 8 DP - 2012 Aug TI - Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. PG - 1683-95 LID - 10.1016/j.clinthera.2012.06.024 [doi] AB - BACKGROUND: Fluticasone furoate (FF) is an inhaled corticosteroid that is structurally and functionally distinct from fluticasone propionate and is under development as a once-daily therapy for asthma. OBJECTIVE: The objective of this study was to estimate the treatment differences (with 95% CI) in efficacy and safety profile between FF administered once daily in the morning and evening via Rotadisk Diskhaler (see text) in patients with persistent asthma. No hypothesis testing was performed for this comparison. METHODS: This was a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study. Patients (ages 16-55 years; peak expiratory flow [PEF] 50%-90% predicted) were randomized to receive 1 of 3 doses of FF Rotadisk or placebo daily for 4 weeks. The sponsor, GlaxoSmithKline, designed the study and selected the study sites. The primary end point was change from baseline in daily trough (pretreatment, prebronchodilator) PEF during the treatment period with FF Rotadisk 100 mug once daily in the morning compared with 100 mug once daily in the evening. Other end points included change from baseline in forced expiratory volume in 1 second, asthma symptom score, adverse events (AEs), 24-hour urinary cortisol excretion, and FF pharmacokinetics. RESULTS: Five hundred and seventy-five patients (mean age 36.6 years, 56.9% female) formed the intent-to-treat population and were randomly allocated to FF Rotadisk 100 mug once daily in the morning (n = 144), FF Rotadisk 100 mug once daily in the evening (n = 146), FF Rotadisk 250 mug once daily in the evening (n = 142), or placebo (n = 143). Of these patients, 526 (91.5%) completed the study. A smaller proportion of patients in the placebo group (86.7%) than in the active treatment groups completed the study. Mean difference in PEF change from baseline with FF Rotadisk 100 mug once daily in the morning relative to evening was +13.4 L/min (95% CI, 2.3-24.4). However, morning trough values might have been affected by higher placebo response after morning dosing (18.8 vs 8.8 L/min). Trough PEF improved relative to placebo (P