Phase 4 N=20 Randomized Quadruple-blind Treatment

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

Bronchospasm, Exercise-Induced

Bottom Line

View on ClinicalTrials.gov: NCT01691079 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jun 2020

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ipratropium bromide (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	—	—
SECONDARY Specific IgE Measurements	—	—

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.

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.

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Data sourced from ClinicalTrials.gov (NCT01691079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.