Bronchospasm, Exercise-Induced
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGipratropium bromide
Inhaled ipratropium bromide administered before exercise.
DRUGPlacebo
Inhaled placebo administered before exercise.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Athletes \> 13 years of age
Exclusion criteria
* History of cardiac complaints (chest pain, shortness of breath, palpitations, dyspnea on exertion). * History of cardiac disease or taking cardioactive medications. * History of smoking. * History of glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | The outcome measures will be assessed over an expected average of 6 months. |
Secondary
| Measure | Time frame |
|---|---|
| Specific IgE Measurements | The outcome measures will be assessed over an expected average of 6 months. |
Countries
United States
Participant flow
Recruitment details
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo 2 puffs prior to exercise challenge
Placebo: Inhaled placebo administered before exercise. | 0 |
| Ipratropium Bromide ipratropium bromide HFA 2 puffs prior to exercise challenge
ipratropium bromide: Inhaled ipratropium bromide administered before exercise. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Population: PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Secondary
Specific IgE Measurements
Time frame: The outcome measures will be assessed over an expected average of 6 months.
Population: PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.