The Role of GER in Exercise Triggered Asthma
The Role of GER in Exercise Triggered Asthma
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.
PRIMARY OBJECTIVE

 To determine whether patients with exercise-triggered asthma experience GER during exercise.

 SECONDARY OBJECTIVES

 To determine whether the exercise-induced GER within the subjects relates temporally to their
 exertional asthma.

 To evaluate the efficacy of potent acid suppression with a proton pump inhibitor in
 suppressing exercise-triggered GER and asthma in these subjects.

 METHODS

 Population to be evaluated:

 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.

 These patients will be randomized into three different treatment groups:

 1. Placebo BID

 2. 20 mg Aciphex QD and placebo QPM

 3. 20 mg Aciphex BID

 12 patients will be studied in each group.

 DATA

 pH data - Data will be collected on the frequency and duration of the reflux episodes (number
 of episodes and the percent time the esophageal pH is less than 4.0). This will then be
 correlated with the respiratory symptom and changes in spirometry. A symptom index will be
 designed to associate the episodes of reflux and bronchospasm that occur within 5 minutes of
 a drop in esophageal pH.

 Exercise Tolerance/Symptoms - comparisons will be made between the three groups regarding
 symptomatology during exercise after randomization to either placebo or differing doses of
 Aciphex.

 Spirometry testing - done after exercise test. Comparisons between baseline and following
 treatment Symptoms scores - both the overall numerical grades of the patients quality of life
 and the number of asthmatic episodes and rescue inhaler use will be compared to baseline
 after the 12 week study.

 STUDY DURATION

 The asthma database at the University covers approximately 500 patients. A database search
 will be performed to identify patients suitable for recruitment. Additional recruitment, if
 needed, will be pursued through radio advertising. Once the study is initiated, the baseline
 time for therapy is 12 weeks for each patient. An estimate of the time necessary to complete
 the study is 15 months.

 STATISTICS

 Exercise triggered asthma has not been well studied with respect to its relationship to GER.
 This study will be considered a pilot study with 12 subjects per arm. Results from this study
 may be used to power a follow up study.
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)