Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes (STAMINA)
Primary Purpose
Bronchospasm, Exercise-Induced
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ipratropium bromide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchospasm, Exercise-Induced
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
ipratropium bromide
Arm Description
placebo 2 puffs prior to exercise challenge
ipratropium bromide HFA 2 puffs prior to exercise challenge
Outcomes
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
Secondary Outcome Measures
Specific IgE Measurements
Full Information
NCT ID
NCT01691079
First Posted
September 13, 2012
Last Updated
May 20, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01691079
Brief Title
Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
Acronym
STAMINA
Official Title
Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchospasm, Exercise-Induced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo 2 puffs prior to exercise challenge
Arm Title
ipratropium bromide
Arm Type
Active Comparator
Arm Description
ipratropium bromide HFA 2 puffs prior to exercise challenge
Intervention Type
Drug
Intervention Name(s)
ipratropium bromide
Other Intervention Name(s)
atrovent
Intervention Description
Inhaled ipratropium bromide administered before exercise.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhaled placebo administered before exercise.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Specific IgE Measurements
Time Frame
The outcome measures will be assessed over an expected average of 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Luke-Zeitoun
Organizational Affiliation
Assistant Clinical Professor (Volunteer)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
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