Exercise-Induced Bronchospasm in Cystic Fibrosis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Cystic Fibrosis Bronchospasm |
| Study Type: | Observational |
| 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
blood, sputum
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Forty patients with cystic fibrosis and mild lung disease (defined by FEV1≥ 70% predicted), age 12 years and older, are our target enrollments.
Inclusion Criteria:
Males and females with confirmed diagnosis of Cystic Fibrosis:
- 2 positive sweat chloride tests (or)
- genetic testing
- Age 12 years and older
- Baseline FEV1 ≥70% predicted
Clinically stable over past 28 days:
- no change in chronic respiratory symptoms
- no need for antibiotics other then chronic maintenance therapies
- no need for oral steroids
- no increased use of bronchodilators
- Visit 1 FEV1 within 10% of baseline
Exclusion Criteria:
- History of Allergic Bronchopulmonary Aspergillosis (ABPA)
- Chronic airway colonization with Burkholderia cepacia (defined as 2 or more prior positive sputum or BAL cultures)
- Pregnancy
- Chronic oral corticosteroid use
- Febrile illness within two weeks of Visit 1
- Unable to provide consent (patients under age of 18 will require both parental consent AND patient assent)
- Current cigarette smoking, cessation of smoking within 6 weeks of Visit 1, or more than 10 pack-years of prior smoking
Contacts and Locations| Contact: Janice E. Drake, CRRT | 614-247-7707 | john.mastronarde@osumc.edu |
| Contact: Sharon Cheung, BS | 614-366-2258 | sharon.cheung@osumc.edu |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43201 | |
| Contact: Janice E Drake, MD 614-366-2287 janice.drake@osumc.edu | |
| Contact: Sharon Cheung, BS 614-366-2258 sharon.cheung@osumc.edu | |
| Sub-Investigator: Stephen Kirkby, MD | |
| Principal Investigator: | John G. Mastronarde, MD | Ohio State University |
More Information
No publications provided
| Responsible Party: | John Mastronarde, MD, John Mastronard M.D., Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00806455 History of Changes |
| Other Study ID Numbers: | 2007H0319 |
| Study First Received: | December 9, 2008 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
to determine how often exercise-induced bronchospasm occurs in cystic fibrosis Exercise-induced bronchospasm in cystic fibrosis |
Additional relevant MeSH terms:
|
Bronchial Spasm Cystic Fibrosis Asthma, Exercise-Induced Fibrosis Bronchial Diseases Respiratory Tract Diseases Pancreatic Diseases Digestive System Diseases Lung Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Asthma Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013