A Phase 4 interventional study of ipratropium bromide and Placebo in Bronchospasm, Exercise-Induced, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.
Exercise-induced asthma (EIA) is common and often unrecognized among endurance athletes. The mechanisms of asthma appear to be different between athletes and non-athletes, in that the occurrence of asthma is higher among endurance athletes and seems to be promoted by training. This suggests that factors inherent to athleticism, such as the parasympathetic nervous system, which has been shown to change with endurance training and is known to lead to narrowing of the airways, may be involved with the development of asthma in athletes. Although asthma mechanisms and treatments have been extensively studied in classic asthmatics, there is very limited data in athletes.
This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.
If ipratropium bromide proves to prevent EIA in athletes, this drug may be appropriate and effective to target EIA in this population. The results of this study may lead to improved clinical management of athletes with asthma.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 20 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
placebo 2 puffs prior to exercise challenge
Drug: Placebo
ipratropium bromide HFA 2 puffs prior to exercise challenge
Drug: ipratropium bromide
Inhaled ipratropium bromide administered before exercise.
Also known as: atrovent
Inhaled placebo administered before exercise.
Spirometry and Specific Airway Conductance Measured by Body Plethysmography Before and After Exercise Challenge After Randomized Administration of Either Inhaled Ipratropium Bromide or Inhaled Placebo
Time frame: The outcome measures will be assessed over an expected average of 6 months.
Specific IgE Measurements
Time frame: The outcome measures will be assessed over an expected average of 6 months.
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
| Milestone | Placebo | Ipratropium Bromide |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | — | — |
| Ipratropium Bromide | — | — | — |
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
| Age, Continuous | Placebo | Ipratropium Bromide | Total |
|---|
| Sex: Female, Male | Placebo | Ipratropium Bromide | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | Placebo | Ipratropium Bromide | Total |
|---|
| Region of Enrollment(participants) | Placebo | Ipratropium Bromide | Total |
|---|
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ipratropium
University of California, San Francisco →