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

Phase 4

Completed

• Conditions: Bronchospasm, Exercise-Induced
• Interventions: Drug: Placebo; Drug: ipratropium bromide

• Registration Number: NCT01691079
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-24
• Study Start: 2012-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2020-05
• Results First Submitted: 2020-05-20
• Results First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Results First Posted: 2020-06-05
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo 2 puffs prior to exercise challenge
ipratropium bromide	ipratropium bromide	ipratropium bromide HFA 2 puffs prior to exercise challenge

Primary Outcome Measures

Name	Time	Method
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	The outcome measures will be assessed over an expected average of 6 months.

Secondary Outcome Measures

Name	Time	Method
Specific IgE Measurements	The outcome measures will be assessed over an expected average of 6 months.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States