NCT00634413已完成2 期
A Phase II, Randomised, Double-Blind, Placebo-Controlled Pilot Efficacy Study of ADC4022 on Markers of Pulmonary Inflammation in Subjects With Moderate to Severe COPD
Pulmagen Therapeutics8 个研究点 分布在 2 个国家目标入组 91 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 8
- 主要终点
- Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
研究概览
简要总结
The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of COPD that has been symptomatic for at least 2 years
- •The subject has moderate to severe COPD, as defined by the American Thoracic Society and the European Respiratory Society
- •The subject can produce an adequate sputum specimen after induction
- •The subject has a history of ≥ 10-pack years of cigarette smoking
- •The subject has either a ≤15% increase or ≤200 ml increase in FEV1 from pre-dose following a fixed dose of bronchodilator therapy
- •The subject is able to provide written, informed consent to participate
排除标准
- •The subject has experienced a respiratory tract infection and/or an exacerbation of COPD within 30 days
- •The subject uses systemic corticosteroids (oral or parenteral)
- •The subject has received long term oxygen therapy within 30 days
- •The subject has a previous history or diagnosis of asthma
- •The subject has a chest x-ray within the past 12 months which is diagnostic of an active or clinically significant disease other than COPD
- •The subject has a history or presence of active tuberculosis, cystic fibrosis, bronchiectasis, lung cancer or sarcoidosis or any other clinically important lung diseases
- •The subject has had radiation or chemotherapy within the previous 12 months
- •The subject has a history of anaphylaxis associated with medicinal products
- •The subject is pregnant, intends to become pregnant, or is breast feeding
- •The subject's alcohol intake is excessive.
- •The subject participated in another study (for a marketed drug) within 3 months before the start of this study or (for an investigational drug) within 4 months before the start of this study.
- •Other inclusion/exclusion criteria may also apply
研究组 & 干预措施
1
Experimental
干预措施: Theophylline - ADC4022 (Drug)
1
Experimental
干预措施: Budesonide (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
2
Placebo Comparator
干预措施: Budesonide (Drug)
结局指标
主要结局
Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
时间窗: Baseline and after 4 weeks treatment
次要结局
- Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum(Baseline and after 4 weeks treatment)
- Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy(Baseline and after 4 weeks treatment)
- Tolerability to ADC4022(Baseline, during 4 weeks treatment and after 1 week of follow-up)
研究者
研究点 (8)
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