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

NCT ID: NCT01691079

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Bronchospasm, Exercise-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

placebo 2 puffs prior to exercise challenge

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhaled placebo administered before exercise.

ipratropium bromide

ipratropium bromide HFA 2 puffs prior to exercise challenge

Group Type: ACTIVE_COMPARATOR

ipratropium bromide

Intervention Type: DRUG

Inhaled ipratropium bromide administered before exercise.

Interventions

ipratropium bromide

Inhaled ipratropium bromide administered before exercise.

Intervention Type: DRUG

Placebo

Inhaled placebo administered before exercise.

Intervention Type: DRUG

Other Intervention Names

atrovent

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Luke-Zeitoun

Role: PRINCIPAL_INVESTIGATOR

Assistant Clinical Professor (Volunteer)

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

12-09621

Identifier Type: -

Identifier Source: org_study_id