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Sponsors and Collaborators: |
University of Montreal University of Ottawa Laval University University of British Columbia McGill University |
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Information provided by: | University of Montreal |
ClinicalTrials.gov Identifier: | NCT00509197 |
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 |
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Non-Eosinophilic Asthma |
Drug: Placebo Drug: Fluticasone |
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? |
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 |
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A: Active Comparator
Inhaled Corticosteroids
|
Drug: Fluticasone
Fluticasone 250mcg bid for one month
|
B: Placebo Comparator
Placebo
|
Drug: Placebo
Fluticasone 250 mcg bid
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine Lemiere, MD,MSc | 514 338 2796 | catherine.lemiere@umontreal.ca |
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 |
Principal Investigator: | Catherine Lemiere, MD,MSc | Hôpital du Sacré-Coeur de Montréal |
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 |
Asthma Non-eosinophilic Asthma sputum eosinophilis Inhaled Corticosteroids |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Fluticasone Asthma Respiratory Hypersensitivity |
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 |