Effect of Vilanterol on Methacholine Challenge Results

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

Detailed Description
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Vilanterol and Fluticasone Furoate
* Drug: Fluticasone Furoate
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilanterol<br>Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler | Drug: Vilanterol and Fluticasone Furoate<br>* Same as vilanterol arm description<br>* Other names: Breo;|
| Experimental: Fluticasone<br>Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler | Drug: Fluticasone Furoate<br>* Same as fluticasone arm description<br>* Other names: Arnuity;|
| Placebo Comparator: Placebo<br>Lactose powder inhaled through Ellipta® inhaler | Drug: Placebos<br>* Same as placebo arm description<br>* Other names: lactose powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment | assessed by dose shift of geometric mean methacholine PC20 data | baseline versus 30 min post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment | assessed by dose shift of geometric mean methacholine PC20 data | baseline versus 24 hours post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methacholine, airway hyperresponsiveness