Effect of Fluticasone Furoate on Methacholine Challenge
- Registration Number
- NCT03898466
- Lead Sponsor
- University of Saskatchewan
- Brief Summary
The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fluticasone Furoate Fluticasone furoate 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 Matching Placebo Matching placebo 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
- Primary Outcome Measures
Name Time Method Methacholine provocation dose causing a 20% fall in FEV1 (PD20) 24 hours post dose, 72 hours post dose and 168 hours post dose Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo
- Secondary Outcome Measures
Name Time Method Fractional exhaled nitric oxide (FeNO) 168 hours Change from baseline on levels of fractional exhaled nitric oxide
Sputum eosinophils Baseline Assessment of induced sputum differential cell counts
Trial Locations
- Locations (1)
Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
🇨🇦Saskatoon, Saskatchewan, Canada