Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes (STAMINA)
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|ClinicalTrials.gov Identifier: NCT01691079|
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Bronchospasm, Exercise-Induced||Drug: ipratropium bromide Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: placebo
placebo 2 puffs prior to exercise challenge
Inhaled placebo administered before exercise.
Active Comparator: ipratropium bromide
ipratropium bromide HFA 2 puffs prior to exercise challenge
Drug: ipratropium bromide
Inhaled ipratropium bromide administered before exercise.
Other Name: atrovent
- 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. ]
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|Ages Eligible for Study:||13 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Athletes > 13 years of age
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691079
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Mona Luke-Zeitoun||Assistant Clinical Professor (Volunteer)|
|Responsible Party:||University of California, San Francisco|
|Other Study ID Numbers:||
|First Posted:||September 24, 2012 Key Record Dates|
|Results First Posted:||June 5, 2020|
|Last Update Posted:||June 5, 2020|
|Last Verified:||May 2020|
Respiratory Tract Diseases
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Molecular Mechanisms of Pharmacological Action