Exercise-Induced Bronchospasm in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of Allergic Bronchopulmonary Aspergillosis (ABPA)
- •Chronic airway colonization with Burkholderia cepacia (defined as 2 or more prior positive sputum or BAL cultures)
- •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
结局指标
主要结局
To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis
时间窗: end of study
次要结局
- 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)
研究者
John Mastronarde, MD
John Mastronard M.D.
Ohio State University