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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01691079
First received: September 13, 2012
Last updated: December 1, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention Phase
Bronchospasm, Exercise-Induced
Drug: ipratropium bromide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specific IgE measurements [ Time Frame: The outcome measures will be assessed over an expected average of 6 months. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo 2 puffs prior to exercise challenge
Drug: Placebo
Inhaled placebo administered before exercise.
Active Comparator: ipratropium bromide
ipratropium bromide HFA 2 puffs prior to exercise challenge
Drug: ipratropium bromide
Inhaled ipratropium bromide administered before exercise.
Other Name: atrovent

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.

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691079

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mona Luke-Zeitoun Assistant Clinical Professor (Volunteer)
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01691079     History of Changes
Other Study ID Numbers: 12-09621 
Study First Received: September 13, 2012
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bromides
Ipratropium
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 30, 2016