Exercise-Induced Bronchospasm in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise-Induced Bronchospasm in Cystic Fibrosis

Conditions
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Cystic Fibrosis, Bronchospasm

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of exercise-induced bronchospasm in those CF patients with evidence of allergic inflammation versus those without allergic inflammation. |  | 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. |  | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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to determine how often exercise-induced bronchospasm, occurs in cystic fibrosis, Exercise-induced bronchospasm in cystic fibrosis