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

• ClinicalTrials.gov Identifier: NCT01691079
• Recruitment Status: Completed
• First Posted: September 24, 2012
• Results First Posted: June 5, 2020
• Last Update Posted: June 5, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: September 13, 2012
• First Posted Date: September 24, 2012
• Results First Submitted Date: May 20, 2020
• Results First Posted Date: June 5, 2020
• Last Update Posted Date: June 5, 2020
• Study Start Date: December 2012
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 20, 2020): 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. ]
• Original Primary Outcome Measures (submitted: September 21, 2012): 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. ]
• Current Secondary Outcome Measures (submitted: May 20, 2020): Specific IgE Measurements [ Time Frame: The outcome measures will be assessed over an expected average of 6 months. ]
• Original Secondary Outcome Measures (submitted: September 21, 2012): Specific IgE measurements [ Time Frame: The outcome measures will be assessed over an expected average of 6 months. ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
• Official Title: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Bronchospasm, Exercise-Induced

Intervention

• Drug: ipratropium bromide
  Inhaled ipratropium bromide administered before exercise.
  Other Name: atrovent
• Drug: Placebo
  Inhaled placebo administered before exercise.

Study Arms

• Placebo Comparator: placebo
  placebo 2 puffs prior to exercise challenge
  Intervention: Drug: Placebo
• Active Comparator: ipratropium bromide
  ipratropium bromide HFA 2 puffs prior to exercise challenge
  Intervention: Drug: ipratropium bromide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2014): 20
• Original Estimated Enrollment (submitted: September 21, 2012): 40
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01691079
• Other Study ID Numbers: 12-09621
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mona Luke-Zeitoun; Assistant Clinical Professor (Volunteer)

• PRS Account: University of California, San Francisco
• Verification Date: May 2020