Completed

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

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What is being tested

Placebo

+ ipratropium bromide

Drug
Who is being recruted

Exercise-Induced Allergies+6

+ Asthma

+ Bronchial Diseases

Over 13 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: June 5, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of California, San Francisco
Last updated: June 5, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Exercise-Induced AllergiesAsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesAsthma, Exercise-Induced

Criteria

1 inclusion criteria required to participate
Athletes > 13 years of age

4 exclusion criteria prevent from participating
History of cardiac complaints (chest pain, shortness of breath, palpitations, dyspnea on exertion)

History of cardiac disease or taking cardioactive medications

History of glaucoma

History of smoking

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
placebo 2 puffs prior to exercise challenge

Group II

Active Comparator
ipratropium bromide HFA 2 puffs prior to exercise challenge

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California, San Francisco

San Francisco, United StatesOpen University of California, San Francisco in Google Maps
CompletedOne Study Center