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Completed

NCT Number: NCT01691079

Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction 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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ipratropium bromide

Drug

Inhaled ipratropium bromide administered before exercise.

Other names: atrovent

Placebo

Drug

Inhaled placebo administered before exercise.

Primary outcomes

  1. 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 outcomes

  1. Specific IgE Measurements

    Time frame: The outcome measures will be assessed over an expected average of 6 months.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: STAMINA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2012
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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