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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo 2 puffs prior to exercise challenge |
|
| ipratropium bromide | Active Comparator | ipratropium bromide HFA 2 puffs prior to exercise challenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipratropium bromide | Drug | Inhaled ipratropium bromide administered before exercise. |
|
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Specific IgE Measurements | The outcome measures will be assessed over an expected average of 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Luke-Zeitoun | Assistant Clinical Professor (Volunteer) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo 2 puffs prior to exercise challenge Placebo: Inhaled placebo administered before exercise. |
| FG001 | Ipratropium Bromide | ipratropium bromide HFA 2 puffs prior to exercise challenge ipratropium bromide: Inhaled ipratropium bromide administered before exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo 2 puffs prior to exercise challenge Placebo: Inhaled placebo administered before exercise. |
| BG001 | Ipratropium Bromide | ipratropium bromide HFA 2 puffs prior to exercise challenge ipratropium bromide: Inhaled ipratropium bromide administered before exercise. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report. | Posted | The outcome measures will be assessed over an expected average of 6 months. |
|
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PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo 2 puffs prior to exercise challenge Placebo: Inhaled placebo administered before exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mona Luke-Zeitoun, MD | University of California, San Francisco | lukezeitounm@peds.ucsf.edu |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo | Drug | Inhaled placebo administered before exercise. |
|
| BG002 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
|
| Secondary | Specific IgE Measurements | PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report. | Posted | The outcome measures will be assessed over an expected average of 6 months. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ipratropium Bromide | ipratropium bromide HFA 2 puffs prior to exercise challenge ipratropium bromide: Inhaled ipratropium bromide administered before exercise. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000092202 |
| Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |