Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids? - Full Text View

Sponsors and Collaborators:	University of Montreal University of Ottawa Laval University University of British Columbia McGill University
Information provided by:	University of Montreal
ClinicalTrials.gov Identifier:	NCT00509197

Purpose

The efficacy of inhaled corticosteroids (ICS) in asthmatic subjects showing no sputum eosinophils is controversial. The broad aim of this study is to assess whether ICS alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects. Methods: We will perform a randomized double-blind, placebo-controlled, multicenter study comparing the efficacy of ICS and placebo for 4 weeks followed by a 4-week open treatment period with ICS/salmeterol in steroid-naïve asthmatic subjects without sputum eosinophilia. The primary outcome will be the the Asthma Control Questionnaire (ACQ) score after four weeks of treatment by ICS or placebo.

This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS and if they further benefit from the addition of a long-acting beta-2 agonists. This study will also determine whether or not the assessment of airway inflammation should be performed in every asthmatic patient in order to give the most appropriate treatment.

Condition	Intervention
Non-Eosinophilic Asthma	Drug: Placebo Drug: Fluticasone

MedlinePlus related topics: Asthma

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

Further study details as provided by University of Montreal:

Primary Outcome Measures:

Asthma Control Questionnaire (ACQ) score after 4 weeks of treatment with ICS or placebo [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1. Asthma Quality of Life Questionnaire (AQLQ) score after 4 weeks of treatment 2. Change in FEV1 3. Change in PC20 [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Inhaled Corticosteroids	Drug: Fluticasone Fluticasone 250mcg bid for one month
B: Placebo Comparator Placebo	Drug: Placebo Fluticasone 250 mcg bid

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Are between 18 and 70 years of age at the time of signing the informed consent.
Have a diagnosis of asthma according to the Guidelines for the Diagnosis and Management of Asthma and have not been treated with ICS in the previous two months.
Have a PC20 methacholine less than 8 mg/ml.
Have a baseline FEV1 greater or equal to 65% of predicted value (at least 6 hours after bronchodilator).
Are not optimally controlled with short-acting 2 agonists as shown by awakenings due to asthmatic symptoms at least once a week, or regular use of salbutamol on 4 or more occasions per week (excluding exercise prophylaxis) due to asthma symptoms.
ACQ score equal or greater than 2
Have sputum eosinophils less than 2%
Are non smokers or ex-smokers who smoked a maximum of 10 pack/year.

Exclusion Criteria:

Hospitalized patients within the last 3 months
Current or recent (within the last month) symptoms of a cold or flu
Patients with a history of near fatal asthma
Subjects on inhaled corticosteroids, prednisone, long-acting beta 2 agonists, montelukast or theophylline, within 2 months prior to entry into the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509197

Contacts

Contact: Catherine Lemiere, MD,MSc

514 338 2796

catherine.lemiere@umontreal.ca

Locations

Canada
Hôpital Laval	Recruiting
Quebec, Canada, G1V 4G5
Contact: Louis-Philippe Boulet, MD 418 6564747 lpboulet@med.ulaval.ca
Principal Investigator: Louis-Philippe Boulet, MD
Canada, British Columbia
Vancouver General Hospital	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Mark J FitzGerald, MD 604 875 4565. Mark.Fitzgerald@vch.ca
Sub-Investigator: Penny Brasher, PhD
Principal Investigator: Mark J FitzGerald, MD
Canada, Ontario
The Ottawa Hospital	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Shawn Aaron, MD 613-739-6636 saaron@ohri.ca
Principal Investigator: Shawn Aaron, MD
Firestone Institute for Respiratory Health	Recruiting
Hamilton, Ontario, Canada
Contact: Parameswaram Nair, MD, PhD 905 522 1155 ext 35044 parames@mcmaster.ca
Principal Investigator: Parameswaran Nair, MD, PhD
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal	Recruiting
Montréal, Quebec, Canada, H4J 1C5
Principal Investigator: Catherine Lemiere, MD,MSc
The Meakins-Christie Laboratories	Not yet recruiting
Montreal, Quebec, Canada, H2X 2P2
Contact: Martin G James, MD 5143864 ext 09388 james.martin@mcgill.ca
Principal Investigator: James G Martin, MD

Sponsors and Collaborators

University of Montreal

University of Ottawa

Laval University

University of British Columbia

McGill University

Investigators

Principal Investigator:

Catherine Lemiere, MD,MSc

Hôpital du Sacré-Coeur de Montréal

More Information

Responsible Party:	Hôpital du Sacré-Coeur de Montréal ( Catherine Lemiere )
Study ID Numbers:	SFA110717
Study First Received:	July 27, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00509197
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Montreal:

Asthma
Non-eosinophilic Asthma
sputum eosinophilis
Inhaled Corticosteroids

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

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 16, 2009