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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
History of Changes

July 27, 2007
February 12, 2009
October 2007
January 2010   (final data collection date for primary outcome measure)
Asthma Control Questionnaire (ACQ) score after 4 weeks of treatment with ICS or placebo [ Time Frame: two years ] [ Designated as safety issue: No ]
Asthma Control Questionnaire (ACQ) score after 4 weeks of treatment with ICS or placebo [ Time Frame: two years ]
Complete list of historical versions of study NCT00509197 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?
Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-Eosinophilic Asthma
  • Drug: Placebo
    Fluticasone 250 mcg bid
  • Drug: Fluticasone
    Fluticasone 250mcg bid for one month
  • Active Comparator: A
    Inhaled Corticosteroids
    Intervention: Drug: Fluticasone
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Catherine Lemiere, MD,MSc 514 338 2796 catherine.lemiere@umontreal.ca
Canada
 
NCT00509197
SFA110717
No
Catherine Lemiere, Hôpital du Sacré-Coeur de Montréal
Université de Montréal
  • University of Ottawa
  • Laval University
  • University of British Columbia
  • McGill University
Principal Investigator: Catherine Lemiere, MD,MSc Hopital du Sacre-Coeur de Montreal
Université de Montréal
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP