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Sponsors and Collaborators: |
University of Utah AstraZeneca |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00444236 |
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 |
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Exercise Triggered Asthma Gastroesophageal Reflux |
Drug: Nexium Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression |
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 |
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1: Active Comparator |
Drug: Nexium
nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
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2: Placebo Comparator |
Drug: Placebo
matching placebo for active drug
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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.
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:
Exclusion Criteria:
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 |
Responsible Party: | University of Utah HSC ( Kathryn A. Peterson, M.D. ) |
Study ID Numbers: | IRB # 20135, Exercise/Asthma |
Study First Received: | March 6, 2007 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00444236 History of Changes |
Health Authority: | United States: Institutional Review Board |
asthma GERD reflux exercise |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder Gastrointestinal Diseases |
Omeprazole Asthma Esophageal Diseases Gastroesophageal Reflux |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |