Effect of Fluticasone Furoate on Methacholine Challenge

Study Overview
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Brief Summary
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The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.

Official Title
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The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fluticasone furoate
* Other: Matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted methacholine PD20 less than or equal to 400mcg no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start Exclusion Criteria: regular use of inhaled corticosteroid within 4 weeks of study start poorly controlled asthma current smoker or ex smoker with greater than 10 pack year history pregnancy or breast-feeding health concern/condition that would preclude participation for safety reasons

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: Fluticasone Furoate<br>Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours. The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints | Drug: Fluticasone furoate<br>* Inhaled corticosteroid<br>* Other names: Arnuity;|
| Placebo Comparator: Matching Placebo<br>Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours. The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints | Other: Matching placebo<br>* Placebo inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methacholine provocation dose causing a 20% fall in FEV1 (PD20) | Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo | 24 hours post dose, 72 hours post dose and 168 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional exhaled nitric oxide (FeNO) | Change from baseline on levels of fractional exhaled nitric oxide | 168 hours | 
| Sputum eosinophils | Assessment of induced sputum differential cell counts | Baseline |