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The Role of GER in Exercise Triggered Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204672
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Achipex Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: The Role of GER in Exercise Triggered Asthma
Study Start Date : October 2000
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine whether patients with exercise-triggered asthma experience GER during exercise.

Secondary Outcome Measures :
  1. To determine whether the exercise-induced GER within the subjects relates temporally to their exertional asthma.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204672

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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
PriCara, Unit of Ortho-McNeil, Inc.
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Principal Investigator: Kathryn A Peterson, M.D. University of Utah

Layout table for additonal information Identifier: NCT00204672    
Other Study ID Numbers: RAB-USA-46
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005
Keywords provided by University of Utah:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases