Exercise-Induced Bronchospasm in Cystic Fibrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00806455|
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : November 19, 2013
|Condition or disease|
|Cystic Fibrosis Bronchospasm|
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.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Exercise-Induced Bronchospasm in Cystic Fibrosis|
|Study Start Date :||July 2008|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
- To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis [ Time Frame: end of study ]
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806455
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43201|
|Principal Investigator:||John G. Mastronarde, MD||Ohio State University|