At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Repeat-dose, Placebo-controlled, Three-way Crossover, Double Dummy Study to Evaluate and Compare the Efficacy of Fluticasone Furoate Inhalation Powder Delivered Via the Single Strip Dry Powder Inhaler When Administered Either in the Morning or in the Evening, in Male and Female Asthmatic Subjects
In Brief
A Phase 2 clinical trial evaluating Fluticasone Furoate (FF) and Placebo for Asthma. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
Placebo in single strip to be administered via dry powder inhaler in the morning and evening for 14 days (+/- 2 days).