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Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes (STAMINA)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Completed
Phase 4

Conditions

Bronchospasm, Exercise-Induced

Treatments

Drug: Placebo
Drug: ipratropium bromide

Study type

Interventional

Funder types

Other

Identifiers

NCT01691079
12-09621

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

13+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
placebo 2 puffs prior to exercise challenge
Treatment:
Drug: Placebo
ipratropium bromide
Active Comparator group
Description:
ipratropium bromide HFA 2 puffs prior to exercise challenge
Treatment:
Drug: ipratropium bromide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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