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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 28, 2014