Effect of Vilanterol on Methacholine Challenge Results

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Vilanterol and Fluticasone Furoate; Drug: Placebos; Drug: Fluticasone Furoate

• Registration Number: NCT03315000
• Lead Sponsor: University of Saskatchewan

Brief 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.

Study Timeline

• Study Start: 2017-10-13
• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• men and women aged 18 or older
• stable mild-to-moderate asthma
• baseline methacholine PC20 less than or equal to 8mg/mL
• FEV1 greater than or equal to 65% of predicted

Exclusion Criteria

• Use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study
• pregnant or nursing
• diabetes
• hypokalemia
• cardiovascular, prostate, kidney, or urinary retention problems
• lactose-intolerant
• allergy-induced asthma symptoms or upper respiratory tract infection within four weeks of study
• current smokers
• past smokers with smoking history >10 pack years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vilanterol	Vilanterol and Fluticasone Furoate	Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler
Placebo	Placebos	Lactose powder inhaled through Ellipta® inhaler
Fluticasone	Fluticasone Furoate	Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler

Primary Outcome Measures

Name	Time	Method
Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment	baseline versus 30 min post-treatment	assessed by dose shift of geometric mean methacholine PC20 data

Secondary Outcome Measures

Name	Time	Method
Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment	baseline versus 24 hours post-treatment	assessed by dose shift of geometric mean methacholine PC20 data

Trial Locations

Locations (1)

Asthma Research Lab - University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada