Trial Outcomes & Findings for Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children. (NCT NCT01581710)
NCT ID: NCT01581710
Last Updated: 2018-04-12
Results Overview
Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
up to 2 weeks
Results posted on
2018-04-12
Participant Flow
Participant milestones
| Measure |
Montelukast to Placebo
Montelukast to placebo: Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
|
Placebo to Montelukast
Placebo to montelukast: Subjects will receive matching placebo. Each treatment period consists of 2 weeks
|
|---|---|---|
|
First Intervention (14days)
STARTED
|
18
|
14
|
|
First Intervention (14days)
COMPLETED
|
18
|
14
|
|
First Intervention (14days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (14days)
STARTED
|
18
|
14
|
|
Washout Period (14days)
COMPLETED
|
18
|
14
|
|
Washout Period (14days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (14days)
STARTED
|
18
|
14
|
|
Second Intervention (14days)
COMPLETED
|
18
|
12
|
|
Second Intervention (14days)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
Baseline characteristics by cohort
| Measure |
Subjects
n=32 Participants
All subjects
|
|---|---|
|
Age, Continuous
|
6.41 years
STANDARD_DEVIATION 0.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Lung function (Forced Expiratory Volume 1, predicted %)
|
92.9 %
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Lung function (Forced Expiratory Volume 1/Forced Vital Capacity, predicted %)
|
86.1 %
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
oscillometric lung function (Resistance at 5Hz, z-score)
|
0.36 z-score
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
oscillometric lung fuction(Reactance at 5Hz, z-score)
|
-1.14 z-score
STANDARD_DEVIATION 0.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 weeksPre Rrs 5: Resistance at 5Hz before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
|
0.73 kPa/L/s
Standard Deviation 0.15
|
0.74 kPa/L/s
Standard Deviation 0.20
|
0.73 kPa/L/s
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: up to 2 weeksPre Xrs 5: Reactance at 5Hz before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)
|
-0.34 kPa/L/s
Standard Deviation 0.11
|
-0.36 kPa/L/s
Standard Deviation 0.15
|
-0.34 kPa/L/s
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: up to 2 weeksPre Rrs10: Resistance at 10Hz before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator
|
0.57 kPa/L/s
Standard Deviation 0.11
|
0.55 kPa/L/s
Standard Deviation 0.15
|
0.55 kPa/L/s
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: up to 2 weeksPre Xrs 10: Reactance at 10Hz before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)
|
-0.15 kPa/L/s
Standard Deviation 0.22
|
-0.20 kPa/L/s
Standard Deviation 0.10
|
-0.19 kPa/L/s
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: up to 2 weeksbaseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function of FEV1 Before the Bronchodilator
|
1.28 L/s
Standard Deviation 0.41
|
1.25 L/s
Standard Deviation 0.47
|
1.28 L/s
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: up to 2 weeksbaseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function of FEV1/FVC Before the Bronchodilator
|
83.55 none (ratio)
Standard Deviation 16.33
|
83.04 none (ratio)
Standard Deviation 1.22
|
85.93 none (ratio)
Standard Deviation 8.06
|
PRIMARY outcome
Timeframe: up to 2 weeksBaseline lung function in maximal mid-expiratory flow before the administration of bronchodilator
Outcome measures
| Measure |
Baseline Lung Function
n=32 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 Participants
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Baseline Lung Function in MMEF
|
1.40 L/s
Standard Deviation 0.54
|
1.38 L/s
Standard Deviation 0.59
|
1.46 L/s
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: up to 2 weeksRelative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100
Outcome measures
| Measure |
Baseline Lung Function
n=30 Participants
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=32 Participants
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Relative Change (%) of FEV1 After the Bronchodilator
|
9.68 % (relative change)
Standard Deviation 13.31
|
5.65 % (relative change)
Standard Deviation 10.34
|
—
|
Adverse Events
Baseline Lung Function
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Weeks After Placebo Administration
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
2 Weeks After Montelukast Administration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baseline Lung Function
n=32 participants at risk
Before placebo or montelukast administration
|
2 Weeks After Placebo Administration
n=30 participants at risk
Subjects will receive placebo. Each treatment period consists of 2 weeks
|
2 Weeks After Montelukast Administration
n=32 participants at risk
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
0.00%
0/32
|
23.3%
7/30
|
3.1%
1/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place