The Role of GER in Exercise Triggered Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Achipex
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Asthma