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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.
 
ClinicalTrials.gov Identifier: NCT00204672
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date September 20, 2005
Study Start Date  ICMJE October 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To determine whether patients with exercise-triggered asthma experience GER during exercise.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To determine whether the exercise-induced GER within the subjects relates temporally to their exertional asthma.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of GER in Exercise Triggered Asthma
Official Title  ICMJE The Role of GER in Exercise Triggered Asthma
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Achipex
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
36
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00204672
Other Study ID Numbers  ICMJE RAB-USA-46
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Investigators  ICMJE
Principal Investigator: Kathryn A Peterson, M.D. University of Utah
PRS Account University of Utah
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP