A Phase 4 interventional study of Albuterol Sulfate and Interval Warm-up exercise in Asthma in Children, Obesity, Childhood and Exercise Induced Bronchospasm, sponsored by University of Nevada, Las Vegas. Terminated at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by University of Nevada, Las Vegas · Phase 4, Interventional, and Prevention
Guidelines from the American Thoracic Society strongly recommend interval warm-up exercise before planned exercise to reduce exercise-induced bronchoconstriction severity. However, no empirical data on the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity are available in obese asthmatic children, where excess fat exerts such an unfavorable burden on the respiratory system, particularly during exercise. The objective of this study is to investigate the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity in obese and nonobese asthmatic children. Our approach will be to investigate exercise tolerance, respiratory function, and exercise-induced bronchoconstriction severity and the effects of (1) 8x30sec interval warm-up \& (2) pretreatment with a bronchodilator compared with a no-treatment control on exercise-induced bronchoconstriction severity in 8-12 yr, prepubescent, obese and nonobese asthmatic children.
[Aim]: To investigate the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity. [Hypothesis]: Interval warm-up exercise will reduce exercise-induced bronchoconstriction severity after an exercise challenge test to a similar extent as bronchodilator and better than control.
Note related to early termination: Although the intent of the study was to compare obese and nonobese children, early termination precluded us from completing this analysis and thus the pooled results are included in the results. The brief summary has been updated to reflect the presented results.
The investigators will enroll prepubescent, 8 - 12 yr old, obese (body mass index > 95th percentile; N=25) and nonobese (body mass between 16th and 84th percentile; N=25) children with mild asthma. The investigators will investigate the severity of exercise-induced bronchoconstriction during planned exercise performed 15 minutes after the following three conditions performed on separate days in a random order: (1) 8x30sec interval warm-up, (2) short-acting beta agonist or albuterol, \& (3) control, in prepubescent, 8 - 12 yr old, obese and nonobese children with mild asthma.
The investigators will measure the following in all participants:
Three conditions that will precede the exercise challenge include:
Control visit was always completed first. The order of the albuterol and interval warm-up exercise visits was randomized.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Order albuterol and then interval warm up (IWU)
Drug: Albuterol Sulfate · Behavioral: Interval Warm-up exercise
Order is interval warm up (IWU) and then albuterol
Drug: Albuterol Sulfate · Behavioral: Interval Warm-up exercise
Participants will inhale 2 puffs of albuterol (90mcg per actuation). After 15 minutes, participants will undergo an exercise induced bronchoconstriction test
Also known as: Ventolin
Participants will undergo eight 30 sec bouts of high intensity exercise with 45 second recovery between bouts. After 15 minutes, participants will undergo an exercise induced bronchoconstriction test
Maximum % Change in Forced Expiratory Volume in the First Second (FEV1)
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.
Time frame: The change in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction test
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.
| Milestone | Order 1: Albuterol First, Interval Warm-up Second | Order 2: Interval Warm-up First, Albuterol Second |
|---|---|---|
| Started | 6 | 12 |
| Completed | 6 | 11 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Milestone | Order 1: Albuterol First, Interval Warm-up Second | Order 2: Interval Warm-up First, Albuterol Second |
|---|---|---|
| Started | 6 | 11 |
| Completed | 6 | 10 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| percentage change | Albuterol First | Interval Warm-up First |
|---|---|---|
| Control | 1.91 ± 7.47 | -0.84 ± 12.22 |
| Albuterol | 7.98 ± 17.12 | 13.03 ± 6.72 |
| Interval Warm up | 1.12 ± 14.90 | -1.72 ± 11.11 |
Collected over For our participants, the five visits were completed within 6.9 ± 2.4 weeks (Range: 3.6-11.1 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albuterol Intervention | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Interval Warm-up Intervention | 0/18 (0%) | 0/18 (0%) | 2/18 (11.1%) |
| Event | Albuterol Intervention | Interval Warm-up Intervention |
|---|---|---|
| Vocal cord dysfunction during exerciseRespiratory, thoracic and mediastinal disorders | 0/16 | 1/12 |
| Leg painMusculoskeletal and connective tissue disorders | 0/16 | 1/12 |
Baseline analysis is shown for all randomized participants including the two participants who did not complete the interval warm-up first arm.
| Age, Continuous(years) | Albuterol First | Interval Warm up First | Total |
|---|---|---|---|
| Mean | 10.6 ± 0.9 | 10.4 ± 1.0 | 10.5 ± 0.9 |
| Sex: Female, Male(Participants) | Albuterol First | Interval Warm up First | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 2 | 10 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Albuterol First | Interval Warm up First | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 2 | 6 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Albuterol First | Interval Warm up First | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 10 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(participants) | Albuterol First | Interval Warm up First | Total |
|---|---|---|---|
| United States | 6 | 12 | 18 |
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Plan to share: No — There is no current plan to share individual participant data.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albuterol
University of Nevada, Las Vegas