Relative Potency of Inhaled Corticosteroids

Phase 4

Completed

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT00292838
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-16
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Sputum eosinophils

Secondary Outcome Measures

Name	Time	Method
Exhaled nitric oxide, FEV1, FEF25-75%

Trial Locations

Locations (1)

Firestone Institute for Respiratory Health, St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada