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

NCT00444236 | Terminated Phase 1 DMC

• 2 other identifiers: IRB # 20135Exercise/Asthma
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Triggered Asthma; Gastroesophageal Reflux

Keywords

asthma; GERD; reflux; exercise

Outcome Measures

Primary Outcomes (1)

• To assess whether acid suppression results in improvement in respiratory parameters in symptomatic patients.

  6 months

Secondary Outcomes (2)

• To assess whether acid reflux events increase during exercise in athletes with symptomatic heartburn or respiratory discomfort during exertion.

  6 months

• To assess whether long term acid suppression results in enhanced athletic performance

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Nexium

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nexium DRUG

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

Also known as: esomeprazole

1

Placebo DRUG

matching placebo for active drug

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Asthma; Motor Activity

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kathryn A Peterson, MD, MSci

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

US (1)