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The Role of GER in Exercise Triggered Asthma

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00204672
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: Achipex
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: The Role of GER in Exercise Triggered Asthma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

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

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

Estimated Enrollment: 36
Study Start Date: October 2000
Estimated Study Completion Date: September 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204672

Locations
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.
Investigators
Principal Investigator: Kathryn A Peterson, M.D. University of Utah
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204672     History of Changes
Other Study ID Numbers: RAB-USA-46
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013