Ultrasensitive Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine for Inhalation Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Gene biomarker panel
研究概览
简要总结
In cystic fibrosis, there is a critical need for better predictors of treatment response. The investigators have identified a panel of white blood cell biomarkers which can be directly measured as a blood test in subjects with cystic fibrosis. These biomarkers predict reduction of airway inflammation and infection more accurately than lung function testing, in patients receiving intravenous antibiotic therapy. In the current study, we hypothesize that this panel of gene biomarkers which can be readily measured from peripheral blood will sensitively predict changes in inflammation when patients receive inhaled antibiotic therapy, specifically Cayston (or inhaled aztreonam lysine). Patients enrolled in the study will have blood drawn before and after a month of inhaled Cayston, in order to test whether genes predict response to Cayston therapy more robustly than do standard measures such as lung function tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of cystic fibrosis
- •Age 18 years old or greater
- •FEV1 percent predicted greater than 25%
- •Ability to perform reproducible pulmonary function tests and produce sputum spontaneously
- •Chronic bacterial colonization with Pseudomonas aeruginosa with 2 positive cultures in previous 2 years.
- •Chronically stable pulmonary condition without evidence of acute pulmonary exacerbation within 14 days prior to screening
- •Starting Cayston cycle as part of clinical care.
排除标准
- •Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
- •Aztreonam allergy, bronchospasm or other contraindication to use of aztreonam.
- •Signs and symptoms of acute pulmonary exacerbation at the time of enrollment or during study.
- •Active infection and treatment for non-tuberculous mycobacteria.
- •Concomitant use of systemic steroids.
- •Use of inhaled antimicrobial agents with activity against Pseudomonas aeruginosa within 28 days prior to Visit 1.
结局指标
主要结局
Gene biomarker panel
时间窗: 1 month
Measurement of gene biomarkers by polymerase chain reaction before and after 1 month of Cayston therapy
次要结局
- C-reactive protein(1 month)
- Interleukin 8(1 month)
- Patient reported symptom scores(1 month)
- Forced expiratory volume in 1 second (FEV1)(1 month)
- Sputum Bacterial Density(1 month)