Trial Outcomes & Findings for Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids? (NCT NCT00509197)
NCT ID: NCT00509197
Last Updated: 2016-08-15
Results Overview
Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.
TERMINATED
NA
12 participants
Four weeks
2016-08-15
Participant Flow
Participant milestones
| Measure |
Fluticasone 500 mcg Bid
Treatment with Inhaled Corticosteroids
|
Placebo
treatment with placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?
Baseline characteristics by cohort
| Measure |
Fluticasone 500 mcg Bid
n=6 Participants
Treatment with inhaled corticosteroids
|
Placebo
n=6 Participants
Treatment with placebo
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 15.3 • n=99 Participants
|
43 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
40.5 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Four weeksPopulation: Intention to treat
Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.
Outcome measures
| Measure |
Fluticasone
n=6 Participants
Treatment with inhaled corticosteroids
|
Placebo
n=6 Participants
Use of placebo inhaler (sham fluticasone)
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo
|
1.4 units on a scale
Standard Deviation 0.5
|
2.2 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Four weeksValidated questionnaire assessing quality of life related to asthma after 4 weeks of treatment. The AQLQ is composed of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The AQLQ score is rated on a 7-point scale (1=maximal impairment, 7=no impairment) to yield a mean score out of 7. The worse the quality of life is , the lower the score is.
Outcome measures
| Measure |
Fluticasone
n=6 Participants
Treatment with inhaled corticosteroids
|
Placebo
n=6 Participants
Use of placebo inhaler (sham fluticasone)
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment
|
5.5 units on a scale
Standard Deviation 1.2
|
4.8 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Four weeksChange in forced expiratory volume in one second (FEV1) after fluticasone or placebo treatment.
Outcome measures
| Measure |
Fluticasone
n=6 Participants
Treatment with inhaled corticosteroids
|
Placebo
n=6 Participants
Use of placebo inhaler (sham fluticasone)
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1)
|
0.04 L
Standard Deviation 0.1
|
-0.2 L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Four weeksChange in provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) after fluticasone or placebo treatment
Outcome measures
| Measure |
Fluticasone
n=6 Participants
Treatment with inhaled corticosteroids
|
Placebo
n=6 Participants
Use of placebo inhaler (sham fluticasone)
|
|---|---|---|
|
Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)
|
3.4 mg/ml
Standard Deviation 0.6
|
2.1 mg/ml
Standard Deviation 2.6
|
Adverse Events
Fluticasone 500 mcg Bid
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Catherine Lemiere
Hôpital du Sacré-Coeur de Montréal
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place