Status:

COMPLETED

Relative Potency of Inhaled Corticosteroids

Lead Sponsor:

St. Joseph's Healthcare Hamilton

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Asthma

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

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 wi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2001

Trial Type :

INTERVENTIONAL

End Date :

February 1 2007

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00292838

Start Date

January 1 2001

End Date

February 1 2007

Last Update

July 20 2011

Active Locations (1)

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Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, Canada, L8N 4A6