Trial Outcomes & Findings for Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity (NCT NCT03586544)
NCT ID: NCT03586544
Last Updated: 2021-07-22
Results Overview
The change in FEV1 from before to after the exercise induced bronchoconstriction test. For the control condition, the change in FEV1 was measured from before the 6min exercise challenge test to up to 30 min after the exercise challenge test. The control condition was completed before participants were randomized to either albuterol or interval warm-up. This "control" condition is our reference condition because any improvement noted with albuterol or interval warm-up exercise should be compared against the control condition.
TERMINATED
PHASE4
34 participants
The change in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction test
2021-07-22
Participant Flow
Dates of recruitment: 34 participants were screened for eligibility between 9/18/2018 - 3/13/2020. Participants were recruited from the Children's Lung Specialists Pediatric Pulmonology clinic.
18 out of 34 enrolled participants were randomized. Of those not randomized (N=16), 10 did not meet inclusion criteria, 5 declined to participate, and 1 was not randomized because we terminated the study early. Of the 18 participants randomized, 2 did not complete all study visits: 1 because they declined to continue and 1 because of leg pain during exercise.
Participant milestones
| Measure |
Order 1: Albuterol First, Interval Warm-up Second
Participants first received albuterol on one day only. After at least 72 h, they completed the interval warm up on one day only. This was an acute study. There is no washout per se.
|
Order 2: Interval Warm-up First, Albuterol Second
Participants first completed interval warm up exercise on one day only. After at least 72 h, they recieved the albuterol (180ug) on one day only. This was an acute study. There is no washout per se.
|
|---|---|---|
|
First Intervention
STARTED
|
6
|
12
|
|
First Intervention
COMPLETED
|
6
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
6
|
11
|
|
Second Intervention
COMPLETED
|
6
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Order 1: Albuterol First, Interval Warm-up Second
Participants first received albuterol on one day only. After at least 72 h, they completed the interval warm up on one day only. This was an acute study. There is no washout per se.
|
Order 2: Interval Warm-up First, Albuterol Second
Participants first completed interval warm up exercise on one day only. After at least 72 h, they recieved the albuterol (180ug) on one day only. This was an acute study. There is no washout per se.
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
|
Second Intervention
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
Baseline characteristics by cohort
| Measure |
Albuterol First
n=6 Participants
Children will complete an exercise induced bronchoconstriction test preceded by: 1) Control, 2) pretreatment with 'Albuterol' and 3) interval warm-up exercise and
Control visit was always completed first. The order of albuterol and interval warm-up was randomized. In this arm, albuterol visit was completed first.
|
Interval Warm up First
n=12 Participants
Children will complete an exercise induced bronchoconstriction test preceded by: 1) Control, 2) pretreatment with 'Albuterol' and 3) interval warm-up exercise and
Control visit was always completed first. The order of albuterol and interval warm-up was randomized. In this arm, interval warm-up visit was completed first.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
10.4 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
10.5 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The change in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction testPopulation: Two participants did not complete the interval warm-up arm and there results are not reported.
The change in FEV1 from before to after the exercise induced bronchoconstriction test. For the control condition, the change in FEV1 was measured from before the 6min exercise challenge test to up to 30 min after the exercise challenge test. The control condition was completed before participants were randomized to either albuterol or interval warm-up. This "control" condition is our reference condition because any improvement noted with albuterol or interval warm-up exercise should be compared against the control condition.
Outcome measures
| Measure |
Albuterol First
n=6 Participants
Albuterol first and then interval warm up
|
Interval Warm-up First
n=10 Participants
Interval warm-up first and then albuterol
|
|---|---|---|
|
Maximum % Change in Forced Expiratory Volume in the First Second (FEV1)
Control
|
1.91 percentage change
Standard Deviation 7.47
|
-0.84 percentage change
Standard Deviation 12.22
|
|
Maximum % Change in Forced Expiratory Volume in the First Second (FEV1)
Albuterol
|
7.98 percentage change
Standard Deviation 17.12
|
13.03 percentage change
Standard Deviation 6.72
|
|
Maximum % Change in Forced Expiratory Volume in the First Second (FEV1)
Interval Warm up
|
1.12 percentage change
Standard Deviation 14.90
|
-1.72 percentage change
Standard Deviation 11.11
|
Adverse Events
Albuterol Intervention
Interval Warm-up Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Albuterol Intervention
n=16 participants at risk
180 ug of albuterol given on one day in this acute study.
|
Interval Warm-up Intervention
n=18 participants at risk
Interval warm-up exercise completed on one day in this acute study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord dysfunction during exercise
|
0.00%
0/16 • For our participants, the five visits were completed within 6.9 ± 2.4 weeks (Range: 3.6-11.1 weeks).
|
8.3%
1/12 • Number of events 1 • For our participants, the five visits were completed within 6.9 ± 2.4 weeks (Range: 3.6-11.1 weeks).
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/16 • For our participants, the five visits were completed within 6.9 ± 2.4 weeks (Range: 3.6-11.1 weeks).
|
8.3%
1/12 • Number of events 1 • For our participants, the five visits were completed within 6.9 ± 2.4 weeks (Range: 3.6-11.1 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place