Relative Potency of Inhaled Corticosteroids

Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: fluticasone 25, 50, 100, 200 mcg

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sputum eosinophils

Secondary Outcome Measures

Outcome Measure
Exhaled nitric oxide, FEV1, FEF25-75%

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Frederick E Hargreave, MD, McMaster University

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: February 14, 2006
• First Submitted That Met QC Criteria: February 14, 2006
• First Posted (Estimate): February 16, 2006

Study Record Updates

• Last Update Posted (Estimate): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Eosinophilic bronchitis with asthma; Eosinophilic bronchitis without asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone
• Other Study ID Numbers: RP#01-1929