Relative Potency of Inhaled Corticosteroids

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	St. Joseph's Healthcare GlaxoSmithKline
Information provided by:	St. Joseph's Healthcare
ClinicalTrials.gov Identifier:	NCT00292838

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 IV

MedlinePlus related topics: Asthma Bronchitis COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

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

Primary Outcome Measures:

Sputum eosinophils

Secondary Outcome Measures:

Exhaled nitric oxide, FEV1, FEF25-75%

Estimated Enrollment:	40
Study Start Date:	January 2001
Estimated Study Completion Date:	January 2007

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:

Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
Relevant seasonal allergen exposure within 4 weeks or within the course of the study
Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
Other respiratory diseases
Women who are pregnant or unwilling to use appropriate contraception during the study
Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Contacts and Locations

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

GlaxoSmithKline

Investigators

Principal Investigator:

Frederick E Hargreave, MD

McMaster University

More Information

Study ID Numbers:	RP#01-1929
Study First Received:	February 14, 2006
Last Updated:	September 15, 2006
ClinicalTrials.gov Identifier:	NCT00292838
Health Authority:	Canada: Health Canada

Keywords provided by St. Joseph's Healthcare:

Eosinophilic bronchitis with asthma
Eosinophilic bronchitis without asthma

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Fluticasone
Asthma
Bronchitis
Respiratory Hypersensitivity
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009