Status:
COMPLETED
Exercise-Induced Bronchospasm in Cystic Fibrosis
Lead Sponsor:
Ohio State University
Conditions:
Cystic Fibrosis
Bronchospasm
Eligibility:
All Genders
12+ years
Brief Summary
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 conditio...
Detailed Description
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, m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00806455
Start Date
July 1 2008
End Date
August 1 2013
Last Update
November 19 2013
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43201