Relative Potency of Inhaled Corticosteroids

Overview

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.

Full Title of Study: “Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: February 2007

Interventions

  • Drug: fluticasone 25, 50, 100, 200 mcg

Clinical Trial Outcome Measures

Primary Measures

  • Sputum eosinophils

Secondary Measures

  • Exhaled nitric oxide, FEV1, FEF25-75%

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Joseph’s Healthcare Hamilton
  • Collaborator
    • GlaxoSmithKline
  • Overall Official(s)
    • Frederick E Hargreave, MD, Principal Investigator, McMaster University

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