Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Eosinophilic bronchitis with asthma, Eosinophilic bronchitis without asthma
Brief summary
To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.
Interventions
DRUGfluticasone 25, 50, 100, 200 mcg
Sponsors
GlaxoSmithKline
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Sputum eosinophilia \>3% * Adults age 18-70 years * History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months. * FEV1 ≥ 60% predicted * Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent. * Able to give written informed consent
Exclusion criteria
1. Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month 2. Relevant seasonal allergen exposure within 4 weeks or within the course of the study 3. Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks 4. Other respiratory diseases 5. Women who are pregnant or unwilling to use appropriate contraception during the study 6. Unable to withhold short-acting ß-agonist treatment for 6 hours before visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum eosinophils | — |
Secondary
| Measure | Time frame |
|---|---|
| Exhaled nitric oxide, FEV1, FEF25-75% | — |
Countries
Canada
Outcome results
None listed