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NCT03586544 · ClinicalTrials.gov registry record · Phase 4
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
A Phase 4 study, sponsored by University of Nevada, Las Vegas.
- Terminated
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT03586544: Clinical Trial Phase 4 study, sponsored by University of Nevada, Las Vegas.
NCT03586544 is a Phase 4 study that was terminated before completion, run by University of Nevada, Las Vegas. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03586544, a Phase 4 study, was terminated before completion, sponsored by University of Nevada, Las Vegas.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Albuterol Sulfate
- BEHAVIORAL Interval Warm-up exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2021-03-30 |
| Phase | Phase 4 |
Why NCT03586544 stopped before completion
NCT03586544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Albuterol Sulfate is the first listed.
NCT03586544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03586544 about?
NCT03586544 is a clinical study titled "Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity". 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 avai...
What is the current status of trial NCT03586544?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2018-09-18. Estimated completion is 2021-03-30.
What interventions are being tested in trial NCT03586544?
The interventions under investigation include: Albuterol Sulfate (DRUG), Interval Warm-up exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT03586544?
This trial is sponsored by University of Nevada, Las Vegas, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03586544's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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