A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.

Summary

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).

Timeline

Start

2016-04-29

Primary completion

2017-02-21

Completion

2017-02-21

Publications

• Daley-Yates P, Keppler B, Baines A, Bardsley G, Fingleton J. Metabolomic changes related to airway inflammation, asthma pathogenesis and systemic activity following inhaled fluticasone furoate/vilanterol: a randomized controlled trial. Respir Res. 2022 Sep 20;23(1):258. doi: 10.1186/s12931-022-02164-w.
• Bardsley G, Daley-Yates P, Baines A, Kempsford R, Williams M, Mallon T, Braithwaite I, Riddell K, Joshi S, Bareille P, Beasley R, Fingleton J; study team. Anti-inflammatory duration of action of fluticasone furoate/vilanterol trifenatate in asthma: a cross-over randomised controlled trial. Respir Res. 2018 Jul 13;19(1):133. doi: 10.1186/s12931-018-0836-6.

Drugs

Indications