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

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.

Condition or disease	Intervention/treatment	Phase
Bronchospasm, Exercise-Induced	Drug: ipratropium bromide; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes
• Study Start Date: December 2012
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Specific IgE Measurements [ Time Frame: The outcome measures will be assessed over an expected average of 6 months. ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: 12-09621
• First Posted: September 24, 2012
• Results First Posted: June 5, 2020
• Last Update Posted: June 5, 2020
• Last Verified: May 2020

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