Mechanisms of Exercise-induced Bronchospasm

This study has been completed.
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00701025
First received: June 17, 2008
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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
Exercise-induced Bronchospasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Exercise-induced Bronchospasm

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • To compare markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH). [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to identify important differences between non-asthmatics and asthmatics that suffer from EIB [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood, sputum, urine for pregnancy testing


Estimated Enrollment: 70
Study Start Date: April 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
35 asthmatic participants with EIB
2
35 without EIB

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

EIB is one of the most common triggers of bronchospasm in asthmatics. It is identified as a trigger in 80-90% of asthmatics. It also occurs frequently (10-15%) in healthy volunteers without asthma. Inclusion of a heterogenous population of asthmatics and non-asthmatics will help provide much needed information to help compare/contrast EIB that occurs in these two groups.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00701025

Locations
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Jonathan P. Parsons, The Ohio State University
ClinicalTrials.gov Identifier: NCT00701025     History of Changes
Other Study ID Numbers: 2007H0189
Study First Received: June 17, 2008
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
inflammation in asthmatic and non-asthmatic participants

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014