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Mechanisms of Exercise-induced Bronchospasm

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT00701025
Collaborator
(none)
70
Enrollment
1
Location
34
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The term exercise-induced bronchospasm (EIB) describes acute, transient airway narrowing that occurs during, and most often after, exercise. Manifestations of EIB can range from mild impairment of performance to severe bronchospasm and respiratory failure.

The pathogenesis of EIB remains controversial and the role of airway inflammation has not yet been definitively characterized. We plan on comparing markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH). We also will collect demographic information as well as information about asthma control and exercise habits.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    At Visit 1, participants will complete questionnaires about demographics, asthma control (if asthmatic) and exercise habits. The participants will have baseline spirometry performed, and skin prick testing for allergies. Skin testing is important as it can influence the level of exhaled nitric oxide and hence we would like to adjust our results for the presence of allergies. Subsequently, volunteers will undergo sputum induction and then have peripheral blood drawn for microRNA analysis. MicroRNA's are single-stranded RNA molecules of about 21-23 nucleotides in length regulating gene expression. Patterns of MicroRNA expression have been linked to heart disease and cancer. Similar patterns have not been identified in exercise-induced asthma. In total, including time for questions and recovery, the time for Visit 1 will be approximately 3 hours.

    At Visit 2, which will occur 24 hours to 7 days after Visit 1 in order to minimize risk of asthma exacerbation, the participants will again have baseline spirometry. Baseline exhaled nitric oxide will be performed. Eucapnic Voluntary hyperventilation testing will then be performed. They then will have a second exhaled nitric oxide quantification, will undergo sputum induction and then have peripheral blood drawn for microRNA analysis, all occurring after EVH testing. In total, including time for questions and recovery, the time for Visit 2 will be approximately 2 hours.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mechanisms of Exercise-induced Bronchospasm
    Study Start Date :
    Apr 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2011
    Actual Study Completion Date :
    Feb 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    1

    35 asthmatic participants with EIB
    2

    35 without EIB

    Outcome Measures

    Primary Outcome Measures

    1. To compare markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH). [1 week]

    Secondary Outcome Measures

    1. to identify important differences between non-asthmatics and asthmatics that suffer from EIB [1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Men and women

    2. History of physician-diagnosed asthma

    3. Age between 18 and 70 years old.

    4. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. These requirements for contraception also apply to women who may have irregular or absent menstrual periods.

    5. Non-smoker for 6 months or longer

    6. Less than 10 pack year (number of packs per day (x) years of smoking = pack years) smoking history

    Exclusion Criteria:

    1. Objective evidence of severe lung impairment on pulmonary function testing performed at the beginning of the study.

    2. Participation in another interventional research trial

    3. Unable to provide consent

    4. Pregnancy

    5. Asthma exacerbation within the last 4 weeks.

    6. History of severe reaction to allergy skin testing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

    • Principal Investigator: Jonathan P. Parsons, M.D., Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonathan Parsons, Professor of Clinical Internal Medicine, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT00701025
    Other Study ID Numbers:
    • 2007H0189
    First Posted:
    Jun 19, 2008
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by Jonathan Parsons, Professor of Clinical Internal Medicine, Ohio State University
    inflammation in asthmatic and non-asthmatic participants
    Additional relevant MeSH terms:
    Bronchial Spasm
    Asthma, Exercise-Induced

    Study Results

    No Results Posted as of Nov 1, 2021