Effects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.
研究概览
简要总结
The hypothesis being tested is that inhibition of the enzyme known as elastase in the airways of patients with cystic fibrosis will help decrease the number of bacteria. Alpha1 antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by aerosol therapy twice in 1 day and sputum will be collected to measure the density of bacteria
详细描述
Cystic fibrosis is usually characterized by chronic bacterial infections of the airways. Neutrophils release the enzyme elastase in the airways and this enzyme can prevent the ingestion and killing of bacteria by the airway phagocytic cells. The hypothesis being tested is that inhibition of elastase in the airways will help neutrophils decrease the number of bacteria. Each subject with cystic fibrosis will first undergo aerosol therapy with a sterile saline solution and sputum will be collected 2, 4 and 6 hours after the aerosol therapy to measure the density of bacteria. Subsequently, alpha1 antitrypsin, an elastase inhibitor, will be given to the same patients by aerosol therapy twice in 1 day and sputum will be collected at 2, 4 and 6 hours after treatment to measure the density of bacteria. The results will be compared to those obtained after after aerosol therapy with saline solution.
Study phase II
Study type Interventional
Study design Purpose - treatment Allocation - nonrandomized trial Masking - open Control - active Assignment - cross-over Endpoint - efficacy
Primary Outcome Measure Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis
- •Age 14 years and older
- •Women must have a negative pregnancy test and used effective contraception
- •Must be able to produce sputum
- •Sputum culture positive for Pseudomonas aeruginosa
排除标准
- 未提供
研究组 & 干预措施
Prolastin
Prolastin 250 mg nebulized BID, 10 days
干预措施: Prolastin (drug) (Drug)
结局指标
主要结局
Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.
时间窗: 6 hours after Prolastin
次要结局
- Alpha1 antitrypsin in sputum(6 hours after Prolastin)
- Neutrophil burden in airways as determined by sputum myeloperoxidase;(6 hours after Prolastin)
- Sputum elastase activity(6 hours after Prolastin)
研究者
André Cantin
Doctor
Université de Sherbrooke