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

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

  Hide 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

  Hide 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

  Show All Outcome Measures

1. Primary:

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

  Show Outcome Measure 1

2. Secondary:

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

  Show Outcome Measure 2

3. Secondary:

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

  Show Outcome Measure 3

4. Secondary:

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

  Show Outcome Measure 4

  Serious Adverse Events

  Show Serious Adverse Events

  Other Adverse Events

  Show Other Adverse Events

  Limitations and Caveats

  Hide 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

  Hide 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