Gastroesophageal Reflux Clinical Trial
Official title:
Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression
Verified date | January 2016 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
We propose that acid reflux affects respiratory dynamics (breathing) in patients who are exercising and that athletes improve their exercise capacity with acid suppression therapy. It is our intent to determine whether treatment of GER with strong acid suppression may alleviate symptoms, improve exercise capacity, and improve quality of life.
Status | Terminated |
Enrollment | 31 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - We plan to take athletes (cyclists) with GER (heartburn symptoms on a daily-weekly basis which are either improved by a trial of acid suppression or objectively documented via pH/endoscopic testing- this may include during exercise) who experience one or more of the following symptoms during exercise, limiting their perceived ability to exercise to full capacity: - choking - cough - wheezing - shortness of breath - chest tightness during exercise - Athletes will be defined as persons who exercise on a routine basis (at least 3 times a week on average) for at least the past 6 months. - Subjects must be at least 18 years old. Exclusion Criteria: - Pregnancy - Age less than 18 years or greater than 65 years - Abnormal methacholine challenge tests will not exclude one from enrollment as (has been documented in a prior study) often patients with GER will have heightened bronchial reactivity. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients. | 6 months | No | |
Secondary | To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion. | 6 months | No | |
Secondary | To assess whether long term acid suppression results in enhanced athletic performance | 6 months | No |
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