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Mechanisms of Exercise-Induced Bronchospasm
This study is currently recruiting participants.
Study NCT00701025   Information provided by Ohio State University
First Received: June 17, 2008   Last Updated: January 8, 2009   History of Changes

June 17, 2008
January 8, 2009
April 2008
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00701025 on ClinicalTrials.gov Archive Site
to identify important differences between non-asthmatics and asthmatics that suffer from EIB [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
 
Mechanisms of Exercise-Induced Bronchospasm
Mechanisms of Exercise-Induced Bronchospasm

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.

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.

 
Observational
Cohort, Prospective
Exercise-Induced Bronchospasm
 
  • 35 asthmatic participants with EIB
  • 35 without EIB
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
70
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Janice E. Drake, CRT 614-366-2287 janice.drake@osumc.edu
Contact: Sharon Cheung, B.S. 614-366-2258 sharon.cheung@osumc.edu
United States
 
NCT00701025
Jonathan P. Parsons, The Ohio State University
2007H0189
Ohio State University
 
Principal Investigator: Jonathan P. Parsons, M.D. Ohio State University
Ohio State University
January 2009

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