Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Exercise Triggered Asthma Gastroesophageal Reflux |
Drug: Nexium Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression |
- To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To assess whether long term acid suppression results in enhanced athletic performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 34 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Nexium
nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
Other Name: esomeprazole
|
| Placebo Comparator: 2 |
Drug: Placebo
matching placebo for active drug
Other Name: placebo
|
Detailed Description:
This is a randomized, blinded, cross-over trial. We plan to take athletes with classical GER, cough, shortness of breath, chest tightness during exercise and subject them to complete pulmonary function testing in conjunction with exercise and pH testing. We will assess whether such athletes experience an increase in reflux duration and episodes during exercise. The athletes will be randomized (in a cross over fashion) to acid suppression (BID Nexium 40 mg) or placebo for 10-12 weeks. Both the athletes and investigators will be blinded. After 10-12 weeks, exercise testing (ramp protocol with VO2 and anaerobic threshold) with concurrent respiratory function testing will be repeated along with symptom assessment. After a brief washout period of 1-2 weeks, the athletes will then cross-over to the other study medication for 10-12 weeks. Again, at the end of the study period, symptomatic relief as well as respiratory function improvement will be assessed by repeating the initial exercise regimen. The exercise regimens during these medication regimens will not be held stable as indirectly, as a results of "feeling better or worse" from the medication/placebo, these patients may increase/ decrease their exercise routine, resulting in changes in their overall endurance, anaerobic threshold, etc (our endpoints). By keeping the regimen stable, we do not allow for the changes to occur which are large enough to detect.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Utah | |
| University of Utah Health Sciences Center | |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: | Kathryn A Peterson, MD, MSci | University of Utah |
More Information
No publications provided
| Responsible Party: | Kathryn A. Peterson, M.D., University of Utah HSC |
| ClinicalTrials.gov Identifier: | NCT00444236 History of Changes |
| Other Study ID Numbers: | IRB # 20135, Exercise/Asthma |
| Study First Received: | March 6, 2007 |
| Last Updated: | April 22, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
asthma GERD reflux exercise |
Additional relevant MeSH terms:
|
Asthma Gastroesophageal Reflux Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Esophageal Motility Disorders |
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013