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

History of Changes

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:

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

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

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:

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 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:

Asthma
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013

To Top