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Relative Potency of Inhaled Corticosteroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Fluticasone




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, Older Adult)
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
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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
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Principal Investigator: Frederick E Hargreave, MD McMaster University

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ClinicalTrials.gov Identifier: NCT00292838    
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:
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Asthma
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System 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