The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics
Overview
- Phase
- Phase 4
- Intervention
- Fluticasone furoate
- Conditions
- Asthma
- Sponsor
- University of Saskatchewan
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
Investigators
Don Cockcroft
Professor
University of Saskatchewan
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Fluticasone furoate
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
Intervention: Matching placebo
Outcomes
Primary Outcomes
Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
Time Frame: 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 Outcomes
- Fractional exhaled nitric oxide (FeNO)(168 hours)
- Sputum eosinophils(Baseline)