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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00444236
• Other study ID #: IRB # 20135
• Secondary ID: Exercise/Asthma
• Status: Terminated
• Phase: Phase 1
• First received: March 6, 2007
• Last updated: January 19, 2016
• Start date: April 2007
• Est. completion date: September 2009

Study information

• Verified date: January 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Triggered Asthma
• Gastroesophageal Reflux

Intervention

Drug:
• Nexium
nexium or placebo 40 mg twice a day for 10-12 weeks. Therapy will then be switched for another 10-12 weeks
• Placebo
matching placebo for active drug

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients.		6 months	No
Secondary	To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion.		6 months	No
Secondary	To assess whether long term acid suppression results in enhanced athletic performance		6 months	No