Relative Potency of Inhaled Corticosteroids

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Healthcare Hamilton
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone

Criteria

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