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Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

This study has been terminated.
(Inability to complete the recruitment.)
University of Ottawa
Laval University
University of British Columbia
McGill University
University of Calgary
Information provided by (Responsible Party):
Catherine Lemiere, Université de Montréal Identifier:
First received: July 27, 2007
Last updated: July 5, 2016
Last verified: July 2016
Results First Received: May 26, 2015  
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
Condition: Asthma
Interventions: Drug: Placebo (sham inhaler)
Drug: Fluticasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Fluticasone 500 mcg Bid Treatment with Inhaled Corticosteroids
Placebo treatment with placebo

Participant Flow:   Overall Study
    Fluticasone 500 mcg Bid   Placebo
STARTED   6   6 
COMPLETED   6   6 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Fluticasone 500 mcg Bid Treatment with inhaled corticosteroids
Placebo Treatment with placebo
Total Total of all reporting groups

Baseline Measures
    Fluticasone 500 mcg Bid   Placebo   Total
Overall Participants 
[units: participants]
 6   6   12 
[units: participants]
<=18 years   0   0   0 
Between 18 and 65 years   6   6   12 
>=65 years   0   0   0 
[units: years]
Mean (Standard Deviation)
 38  (15.3)   43  (11.7)   40.5  (13.2) 
[units: participants]
Female   5   2   7 
Male   1   4   5 
Region of Enrollment 
[units: participants]
Canada   6   6   12 

  Outcome Measures
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1.  Primary:   Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo   [ Time Frame: Four weeks ]

2.  Secondary:   Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment   [ Time Frame: Four weeks ]

3.  Secondary:   Change in Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Four weeks ]

4.  Secondary:   Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)   [ Time Frame: Four weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Very small sample size. Impossible to recruit the anticipated number of subjects.

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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr Catherine Lemiere
Organization: Hôpital du Sacré-Coeur de Montréal
phone: 514 338 2796

Responsible Party: Catherine Lemiere, Université de Montréal Identifier: NCT00509197     History of Changes
Other Study ID Numbers: SFA110717
Study First Received: July 27, 2007
Results First Received: May 26, 2015
Last Updated: July 5, 2016
Health Authority: Canada: Ethics Review Committee