Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes (STAMINA)
Drug: ipratropium bromide
|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 ]
|Study Start Date:||December 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691079
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Mona Luke-Zeitoun||Assistant Clinical Professor (Volunteer)|