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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00509197
Recruitment Status : Terminated (Inability to complete the recruitment.)
First Posted : July 31, 2007
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Placebo (sham inhaler)
Drug: Fluticasone

  Participant Flow

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
  Description
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 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
  Description
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 Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   6   12 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (15.3)   43  (11.7)   40.5  (13.2) 
Gender 
[Units: Participants]
     
Female   5   2   7 
Male   1   4   5 
Region of Enrollment 
[Units: Participants]
     
Canada   6   6   12 


  Outcome Measures

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

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.


  More Information

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
e-mail: catherine.lemiere@umontreal.ca



Responsible Party: Catherine Lemiere, Université de Montréal
ClinicalTrials.gov Identifier: NCT00509197     History of Changes
Other Study ID Numbers: SFA110717
First Submitted: July 27, 2007
First Posted: July 31, 2007
Results First Submitted: May 26, 2015
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016