NCT00444236

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Nexium	nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
DRUG	Placebo	matching placebo for active drug

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-03-07
• Last updated: 2016-01-21

Locations

1 site across 1 country: United States