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Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression

This study has been terminated.
(The sponsor decided to terminate the study due to slow enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444236
First Posted: March 7, 2007
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kathryn A. Peterson, University of Utah
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression

Resource links provided by NLM:


Further study details as provided by Kathryn A. Peterson, University of Utah:

Primary Outcome Measures:
  • To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion. [ Time Frame: 6 months ]
  • To assess whether long term acid suppression results in enhanced athletic performance [ Time Frame: 6 months ]

Enrollment: 31
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444236


Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
AstraZeneca
Investigators
Principal Investigator: Kathryn A Peterson, MD, MSci University of Utah
  More Information

Responsible Party: Kathryn A. Peterson, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00444236     History of Changes
Other Study ID Numbers: IRB # 20135
Exercise/Asthma
First Submitted: March 6, 2007
First Posted: March 7, 2007
Last Update Posted: January 21, 2016
Last Verified: January 2016

Keywords provided by Kathryn A. Peterson, University of Utah:
asthma
GERD
reflux
exercise

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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