NCT03315000

Effect of Vilanterol on Methacholine Challenge Results

The Effect of Vilanterol Against Methacholine-induced Bronchoconstriction in Mild Asthmatics

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.

Detailed description

This will be a double-blind, three-way crossover study comparing combination vilanterol+fluticasone with fluticasone monotherapy and a placebo (vilanterol is not available as a monotherapy). The order in which the treatments are given will be randomized and each treatment will be separated by a minimum one-week washout. Fifteen asthmatic participants will be recruited from the local community. Methacholine challenge testing (MCT) with the two-minute tidal breathing protocol will be used to quantify the bronchoprotective effects (if any) of each treatment against methacholine-induced bronchoconstriction. Each participant will undergo a total of nine methacholine challenges. After a baseline methacholine challenge, the randomized treatment (identity unknown to investigator or participant) will be administered through an Ellipta® (multi-dose dry powder inhaler). Thirty minutes following treatment administration, a second methacholine challenge will be performed. At 24 hours post-treatment, each participant must re-visit the lab for one methacholine challenge. The same process will be followed for each treatment.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Vilanterol and Fluticasone Furoate	Same as vilanterol arm description
DRUG	Fluticasone Furoate	Same as fluticasone arm description
DRUG	Placebos	Same as placebo arm description

Timeline

• Start date: 2017-10-13
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-10-19
• Last updated: 2018-10-11

Locations

1 site across 1 country: Canada