Asthma Clinical Trial
Official title:
A Randomised, Placebo-controlled, Double-blind, Two Period Crossover Study to Characterise the Exhaled Nitric Oxide Time Profile as a Biomarker of Airway Inflammation in Adult Asthma Patients Following Repeat Administration of Inhaled Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 mcg.
For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2
receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric
oxide (FeNO) is a non-invasive airway inflammation marker.
In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose
study, the duration of action of fluticasone furoate (FF) will be determined by monitoring
the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in
asthmatic subjects.
Subjects who meet the eligibility criteria will participate in the following two treatment
periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will
be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be
followed by a 21-day monitoring/washout period before crossing over to the next treatment
period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored
up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).
n/a
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