Conditions: Asthma
Keywords: Fluticasone Furoate, FF Inhalation Powder, morning dosing, evening dosing, efficacy, FEV1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: no

Brief summary:
This study will investigate the effects of altering the time of day of dosing (morning or evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose, double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be approximately 13 to18 weeks for each subject.

Detailed description:

Arms:
arm 1: All the subjects in this study will take part in 3 treatment periods and will receive all three treatments (one per period) in a random manner. In one of the treatment periods, subjects will receive FF 100 mcg in the morning (approximately 09:00) and placebo in the evening (approximately 21:00) for 14 days (+/- 2 days). arm 2: All the subjects in this study will take part in 3 treatment periods and will receive all three treatments (one per period) in a random manner. In one of the treatment periods, subjects will receive FF 100 mcg in the evening (approximately 21:00) and placebo in the morning (approximately 09:00) for 14 days (+/-2 days). arm 3: All the subjects in this study will take part in 3 treatment periods and will receive all three treatments (one per period) in a random manner. In one of the treatment periods, subjects in this arm will receive Placebo in the evening and morning (at approximately 09:00 and 21:00) for 14 days (+/- 2 days).

Interventions: intervention 1: Fluticasone Furoate (FF) intervention 2: Placebo
Intervention descriptions: intervention 1: Inhalation powder 100 microgram per blister strip to be administered via dry powder inhaler either in the morning (AM dose with FF and PM dose with +/-2 days). intervention 2: Placebo in single strip to be administered via dry powder inhaler in the morning and evening for 14 days (+/- 2 days).

Protocol document: