Exercise-Induced Bronchospasm in Cystic Fibrosis
Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has been associated with better patient outcomes and quality of life. Exercise-induced bronchospasm is a condition, often associated with asthma, which may make exercise difficult. The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown. This study is designed to determine how often exercise-induced bronchospasm occurs in cystic fibrosis.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Exercise-Induced Bronchospasm in Cystic Fibrosis|
- To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis [ Time Frame: end of study ] [ Designated as safety issue: No ]
- To determine the prevalence of exercise-induced bronchospasm in those CF patients with evidence of allergic inflammation versus those without allergic inflammation. [ Time Frame: end of study ] [ Designated as safety issue: No ]
- To determine the difference in exhaled nitric oxide and other surrogate markers of inflammation, as well as self-reported quality-of-life and symptom scores in CF patients with and without exercise-induced bronchospasm. [ Time Frame: end of study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||July 2008|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
We anticipate that Visit 1 will take approximately three hours. This will include obtaining informed consent, completing baseline demographic and quality of life questionnaires, brief physical exam, measuring exhaled nitric oxide level, skin allergy testing, obtaining blood and sputum samples, and performing pulmonary function testing before and after bronchodilators.
Visit 2 will take approximately two and one-half hours. This will include performing Eucapnic Voluntary Hyperventilation, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.
Visit 3 will take approximately two and one-half hours. This will include performing Cardiopulmonary exercise testing followed by serial spirometry, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806455
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43201|
|Principal Investigator:||John G. Mastronarde, MD||Ohio State University|