NCT01684410已完成2 期
A Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Adverse Events
研究概览
简要总结
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment duration in this study was intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Documentation of CF diagnosis.
- •Have a pre-bronchodilator FEV1 ≥ 40% of predicted at Visit 1 and have a Visit 2 pre-investigational product FEV1 that is ≥ 40% of predicted and within ± 15% of the Visit 1 result.
- •Deemed by the Investigator to be a suitable candidate for serial collection of expectorated sputum.
排除标准
- •Had a pulmonary exacerbation during the 4 weeks before screening (Visit 1) which required the initiation of new antibiotic treatment
- •Have a pulmonary exacerbation during the screening period (between Visit 1 and Visit 2) which requires the initiation of new antibiotic treatment
- •FEV1 < 0.59 liters at the screening visit
- •Respiratory insufficiency with continuous supplemental oxygen therapy, or carbon dioxide retention
- •Elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) that is ≥ 3 times the upper limit of normal for age and gender
- •Smoking during the past 6 months
- •Lung surgery during the past 2 years
- •Positive culture for Burkholderia cepacia or mycobacterium during the past two years.
- •Active allergic bronchopulmonary aspergillosis
- •Pre-treatment sputum collection at Visit 1 or Visit 2 (Randomization) characterized by problems such as inadequate sputum volume or quality.
- •Known selective Immunoglobulin A (IgA) deficiency with known antibody against IgA (anti-IgA antibody).
- •History of anaphylaxis or severe systemic response to any plasma-derived alpha1-proteinase inhibitor preparation or other blood product(s), or to polysorbates.
- •Use of chronic oral steroids during the study. Note: Inhaled corticosteroids that had been administered for at least 4 weeks prior to Visit 1 were permissible during the study.
- •Use of chronic, high dose ibuprofen therapy within 3 weeks of screening and at anytime during the study.
- •Chronic maintenance therapy with systemic antibiotics within 3 weeks of screening and through last dose of investigational product.
- •Use of leukotriene synthesis inhibitor (zileuton) or leukotriene receptor antagonists (montelukast, zafirlukast) within 3 weeks of screening and at anytime during the study.
- •Use of roflumilast within 3 weeks of screening and at any time during the study.
- •Initiation of a new chronic medication or dosage change of a chronic medication for treatment of cystic fibrosis (example: Kalydeco™ [ivacaftor]) within 3 weeks of screening (Visit 1).
结局指标
主要结局
Adverse Events
时间窗: 3 weeks
adverse event frequency
次要结局
未报告次要终点
研究者
研究点 (12)
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