Clinical trial NCT01691079: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
Official title: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchospasm, Exercise-Induced
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: The outcome measures will be assessed over an expected average of 6 months.
Secondary outcomes:
measure: Specific IgE Measurements
timeFrame: The outcome measures will be assessed over an expected average of 6 months.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Assistant Clinical Professor (Volunteer)
name: Mona Luke-Zeitoun
role: PRINCIPAL_INVESTIGATOR
References: