This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Relative Potency of Inhaled Corticosteroids

This study has been completed.
Information provided by:
St. Joseph's Healthcare Hamilton Identifier:
First received: February 14, 2006
Last updated: July 19, 2011
Last verified: July 2011
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)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00292838

Canada, Ontario
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Principal Investigator: Frederick E Hargreave, MD McMaster University
  More Information Identifier: NCT00292838     History of Changes
Other Study ID Numbers: RP#01-1929
Study First Received: February 14, 2006
Last Updated: July 19, 2011

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
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on August 16, 2017