Asthma
Conditions
Brief summary
The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
Interventions
DRUGFluticasone furoate
Inhaled corticosteroid
OTHERMatching placebo
Placebo inhaler
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed