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Relative Potency of Inhaled Corticosteroids

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ClinicalTrials.gov Identifier: NCT00292838
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : July 20, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
St. Joseph's Healthcare Hamilton

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 without asthma.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model
Study Start Date : January 2001
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Fluticasone
U.S. FDA Resources




Primary Outcome Measures :
  1. Sputum eosinophils

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00292838     History of Changes
Other Study ID Numbers: RP#01-1929
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 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
Fluticasone
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