Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes (STAMINA)
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Purpose
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. We will also obtain a blood sample from all athletes to test for allergies and evaluate whether our results are affected by atopic predisposition.
If ipratropium bromide proves to prevent EIA in athletes, this drug may be more appropriate and effective than the currently used beta-2 agonists to target EIA in this population. The results of this study may lead to improved clinical management of athletes with asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Exercise-induced Bronchoconstriction |
Drug: ipratropium bromide Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes |
- 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. ] [ Designated as safety issue: No ]
- Specific IgE measurements [ Time Frame: The outcome measures will be assessed over an expected average of 6 months. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo
placebo 2 puffs prior to exercise challenge
|
Drug: Placebo |
|
Active Comparator: ipratropium bromide
ipratropium bromide HFA 2 puffs prior to exercise challenge
|
Drug: ipratropium bromide |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Mona Luke-Zeitoun, M.D. | 415-502-1907 | lukezeitounm@peds.ucsf.edu |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: Mona Luke-Zeitoun, M.D. | |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01691079 History of Changes |
| Other Study ID Numbers: | 12-09621 |
| Study First Received: | September 13, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bromides Ipratropium Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013