Effect of Vilanterol on Methacholine Challenge Results

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2018-05-01

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vilanterol

Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler

Group Type EXPERIMENTAL

Vilanterol and Fluticasone Furoate

Intervention Type DRUG

Same as vilanterol arm description

Fluticasone

Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler

Group Type EXPERIMENTAL

Fluticasone Furoate

Intervention Type DRUG

Same as fluticasone arm description

Placebo

Lactose powder inhaled through Ellipta® inhaler

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Same as placebo arm description

Interventions

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Vilanterol and Fluticasone Furoate

Same as vilanterol arm description

Intervention Type DRUG

Fluticasone Furoate

Same as fluticasone arm description

Intervention Type DRUG

Placebos

Same as placebo arm description

Intervention Type DRUG

Other Intervention Names

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Breo Arnuity lactose powder

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No