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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2014

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.

Interventions

  • Drug: ipratropium bromide
    • Inhaled ipratropium bromide administered before exercise.
  • Drug: Placebo
    • Inhaled placebo administered before exercise.

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
    • placebo 2 puffs prior to exercise challenge
  • Active Comparator: ipratropium bromide
    • ipratropium bromide HFA 2 puffs prior to exercise challenge

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Specific IgE Measurements
    • Time Frame: The outcome measures will be assessed over an expected average of 6 months.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mona Luke-Zeitoun, Principal Investigator, Assistant Clinical Professor (Volunteer)

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