Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Université de Montréal.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Université de Montréal
Collaborators:
University of Ottawa
Laval University
University of British Columbia
McGill University
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00509197
First received: July 27, 2007
Last updated: February 12, 2009
Last verified: February 2009
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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: The investigators 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids? |
Resource links provided by NLM:
Further study details as provided by Université de Montréal:
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:
- Asthma Quality of Life Questionnaire (AQLQ) score after 4 weeks of treatment [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Change in FEV1 [ Time Frame: Two years ] [ Designated as safety issue: No ]
- 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 |
|---|---|
|
Active Comparator: A
Inhaled Corticosteroids
|
Drug: Fluticasone
Fluticasone 250mcg bid for one month
|
|
Placebo Comparator: B
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, 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 | |
| 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 | |
| The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Shawn Aaron, MD 613-739-6636 saaron@ohri.ca | |
| Principal Investigator: Shawn Aaron, MD | |
| Canada, Quebec | |
| 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 | |
| Hôpital du Sacré-Coeur de Montréal | Recruiting |
| Montréal, Quebec, Canada, H4J 1C5 | |
| Principal Investigator: Catherine Lemiere, MD,MSc | |
| 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 | |
Sponsors and Collaborators
Université de Montréal
University of Ottawa
Laval University
University of British Columbia
McGill University
Investigators
| Principal Investigator: | Catherine Lemiere, MD,MSc | Hopital du Sacre-Coeur de Montreal |
More Information
No publications provided
| Responsible Party: | Catherine Lemiere, Hôpital du Sacré-Coeur de Montréal |
| ClinicalTrials.gov Identifier: | NCT00509197 History of Changes |
| Other Study ID Numbers: | SFA110717 |
| Study First Received: | July 27, 2007 |
| Last Updated: | February 12, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Université de Montréal:
|
Asthma Non-eosinophilic Asthma sputum eosinophilis Inhaled Corticosteroids |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung 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