The Role of GER in Exercise Triggered Asthma

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

HYPOTHESIS

Gastroesophageal reflux is a major contributor to exercise-triggered asthma.

Two groups of patients will be studied: those with asthma who have difficulty with exertion, those without asthma who experience difficulty with exertion. Both groups will experience gastroesophageal reflux (GER) twice of less per week. Patients will complete a treadmill exam to determine their VO2 max. They will then undergo pH monitoring while exercising for 30 minutes at 65-70% of their VO2 max. Subjects will be given placebo or acid suppression pill for 12 weeks. At the end of 12 weeks, the subjects will repeat the exercise (30 minutes) and 24-hour pH study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.

Criteria

Inclusion Criteria:

• Exercise-triggered asthmatics - defined as asthmatics with exertion as their primary exacerbating factor and experiencing less than two episodes of classic gastroesophageal reflux a week.

Exclusion Criteria:

• Exclusion criteria will be the following:

1. Severe asthma (recent or repeated hospitalizations)

2. Severe angina, cardiac arrhythmia's, heart failure, prior MI

3. Respiratory illness e.g. COPD

4. Inability to receive therapy/pH probe

5. Pregnancy

6. Minors, prisoners, individuals unable to give informed consent

7. Prior upper GI surgery (gastrectomy, etc)