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

NCT ID: NCT00444236

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

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.

Conditions

Exercise Triggered Asthma; Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Nexium

Intervention Type: DRUG

nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo for active drug

Interventions

Nexium

nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks

Intervention Type: DRUG

Placebo

matching placebo for active drug

Intervention Type: DRUG

Other Intervention Names

esomeprazole

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kathryn A. Peterson

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn A Peterson, MD, MSci

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

Exercise/Asthma

Identifier Type: -

Identifier Source: secondary_id

IRB # 20135

Identifier Type: -

Identifier Source: org_study_id