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:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kathryn A. Peterson, University of Utah
ClinicalTrials.gov Identifier:
NCT00444236
First received: March 6, 2007
Last updated: July 25, 2013
Last verified: July 2013
  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
Exercise Triggered Asthma
Gastroesophageal Reflux
Drug: Nexium
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Enrollment: 34
Study Start Date: April 2007
Estimated Study Completion Date: August 2013
Primary Completion Date: July 2013 (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
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kathryn A. Peterson, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00444236     History of Changes
Other Study ID Numbers: IRB # 20135, Exercise/Asthma
Study First Received: March 6, 2007
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014