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Relative Potency of Inhaled Corticosteroids

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00292838
First received: February 14, 2006
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Drug: fluticasone 25, 50, 100, 200 mcg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Sputum eosinophils

Secondary Outcome Measures:
  • Exhaled nitric oxide, FEV1, FEF25-75%

Estimated Enrollment: 40
Study Start Date: January 2001
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292838

Locations
Canada, Ontario
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
GlaxoSmithKline
Investigators
Principal Investigator: Frederick E Hargreave, MD McMaster University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00292838     History of Changes
Other Study ID Numbers: RP#01-1929
Study First Received: February 14, 2006
Last Updated: July 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by St. Joseph's Healthcare Hamilton:
Eosinophilic bronchitis with asthma
Eosinophilic bronchitis without asthma

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014