Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes

Condition(s) targeted: Bronchospasm, Exercise-Induced

Intervention: ipratropium bromide (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Mona Luke-Zeitoun, Principal Investigator, Affiliation: Assistant Clinical Professor (Volunteer)

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.

Official title: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Specific IgE measurements

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.

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

University of California, San Francisco, San Francisco, California 94143, United States

Starting date: December 2012
Last updated: December 1, 2014