Effects of Inhaled Alpha-1-anti-trypsin on Proteolytic Activity in BAL of Bronchiectasis Patients With Chronic Bronchial Expectoration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Changes from baseline BAL levels of A1AT
研究概览
简要总结
Aim: to investigate the influence of alpha1-antitrypsin (A1-AT) nebulization on levels of A1-AT in BAL and plasma in patients with stable bronchiectasis.
Method: single-blind placebo-controlled randomised clinical trial. 19 stable bronchiectasis patients with chronic bronchial infection and 10 control patients (without bronchiectasis) underwent a bronchoscopy in order to assess levels and inhibitory capacity of A1AT and neutrophilic elastase. Afterwards, the 19 bronchiectasis patients were randomly allocated to receive inhaled A1AT 250mg diluted in 10ml 0.9% saline solution once a day for a month (Group A, n: 10) or placebo (10ml 0.9% saline solution; group B, n: 9). A new BAL was performed in both groups (A and B) 24 hours after the end of treatment (1month) to re-analyze A1AT and NE.
详细描述
Effects of inhaled alpha-1-anti-trypsin in bronchiectasis patients with chronic bronchial infection.
Introduction: one of the main features of bronchiectasis is chronic and deregulated neutrophilic bronchial inflammation. Excessive neutrophilic elastase (NE) activity has been widely described as part of the characteristic imbalance between proteases and anti-proteolytic enzymes that characterizes airways inflammation and progressive lung damage in bronchiectasis.
Alpha-1-antitrypsin (A1AT) is a protease inhibitor involved in protecting lung tissue from enzymes of inflammatory cells, including neutrophilic elastase, and its concentration rises in case of acute and chronic inflammation. Its reduction or absence is associated with the development of a specific kind of emphysema in case of exposure to tobacco smoking.
Moreover it is likely that its levels could be reduced in bronchiectasis as a consequence of chronic bronchial infection and inflammatory deregulation.
Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable clinical conditions (no use of systemic antibiotic or steroid treatment in the last month)
- •diagnosis of bronchiectasis bt CT scan
- •chronic purulent or mucopurulent expectoration (daily sputum expectoration in the last 6 months or more)
排除标准
- •Cystic fibrosis
- •interstitial lung disease as cause of bronchiectasis
研究组 & 干预措施
group A
10 patients randomly allocated received nebulised alpha1-antitrypsin 250mg (diluted in 10ml injectable solution) once a day during 1 month.
Intervention: nebulised alpha1-antitrypsin 250mg (diluted in 10ml injectable solution) once a day during 1 month
干预措施: Group A (Drug)
group B
9 patients randomly allocated received 10ml 0.9%NaCl saline solution nebulised once daily during 1 month.
intervention: 10ml 0.9% Sodium Chloride saline solution nebulised once daily during 1 month.
干预措施: Group B (Drug)
结局指标
主要结局
Changes from baseline BAL levels of A1AT
时间窗: 1 MONTH
Changes from baseline in levels of A1AT in broncho-alveolar lavage at 1 month of treatment with inhaled A1AT
次要结局
- Changes from baseline neutrophil elastase in BAL(1 month)
- Changes from baseline neutrophil elastase inhibitory capacity in BAL(1 month)