Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

St. Joseph's Healthcare Hamilton1 site in 1 country40 target enrollmentJanuary 2001

ConditionsAsthma Chronic Obstructive Pulmonary Disease (COPD)

Drugsfluticasone 25, 50, 100, 200 mcg

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Asthma
Sponsor: St. Joseph's Healthcare Hamilton
Enrollment: 40
Locations: 1
Primary Endpoint: Sputum eosinophils
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

February 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

St. Joseph's Healthcare Hamilton

Eligibility 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

•Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
•Relevant seasonal allergen exposure within 4 weeks or within the course of the study
•Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
•Other respiratory diseases
•Women who are pregnant or unwilling to use appropriate contraception during the study
•Unable to withhold short-acting ß-agonist treatment for 6 hours before visit