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Sponsored by: |
Ohio State University |
Information provided by: | Ohio State University |
ClinicalTrials.gov Identifier: | NCT00701025 |
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 |
MedlinePlus related topics: | Asthma Exercise and Physical Fitness |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Mechanisms of Exercise-Induced Bronchospasm |
blood, sputum, urine for pregnancy testing
Estimated Enrollment: | 70 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
1
35 asthmatic participants with EIB
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2
35 without EIB
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
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, Ohio | |||||
The Ohio State University | Recruiting | ||||
Columbus, Ohio, United States, 43210 | |||||
Principal Investigator: Jonathan P. Parsons, M.D. |
Ohio State University |
Principal Investigator: | Jonathan P. Parsons, M.D. | Ohio State University |
Responsible Party: | The Ohio State University ( Jonathan P. Parsons ) |
Study ID Numbers: | 2007H0189 |
First Received: | June 17, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00701025 |
Health Authority: | United States: Institutional Review Board |
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