Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline
研究概览
简要总结
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
详细描述
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
Patients who met all inclusion criteria will be randomized to receive double-blind treatment with Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily (n = 35) or placebo (n = 35) once daily for 4 weeks.
Patients will be evaluated at 2 consecutive visits: screening & treatment visit (first visit) and after treatment visit (second visit).
Spirometric measurements will be performed at pre-treatment during the first visit and post-treatment at two different time points (23 hr + 15 min and 23 hr + 45 min) during the second visit. The average of the values at 23 hr 15 min and 23 hr 45 min during the second visit will be defined as trough value.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD and on a therapeutic regimen for COPD for a year
- •Patients with post-bronchodilator FEV1/FVC ratio <0.70
- •Patients with post-bronchodilator FEV1≥30% and <80% of predicted normal value.
- •Current smokers or ex-smokers with a smoking history of at least 10 pack-years
- •Patients who have no exacerbation within last 4 weeks
- •Females patients with childbearing potential using effective birth control method
- •Patients who have a capability of communicate with investigator
- •Patients who accept to comply with the requirements of the protocol
- •Patients who signed written informed consent prior to participation
排除标准
- •History of hypersensitivity to drugs contain Acetylcysteine or Doxofylline or other mucolitics or xanthines
- •Patients who use mucolitic and/or xantines derivatives or ephedrine routinely.
- •Patients who use CPAP (continous positive airway measure), BiPAP (bilevel continous positive airway measure) or mechanical ventilation
- •History of chronic respiratory diseases except COPD.
- •Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to first visit.
- •Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks.
- •History of significant or uncontrolled disease or operation that may preclude participant from participating in the study
- •Patients who have lung cancer
- •Patients who had lung volume reduction operation
- •Women patients who are pregnant or nursing
- •History of allergic rhinitis or atopy
- •Patients who have known serious prostatic hypertrophy or narrow-angle glaucoma requiring drug therapy
- •History of alcohol abuse.
研究组 & 干预措施
Acetylcysteine/Doxofylline
Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.
干预措施: Acetylcysteine/Doxofylline (Drug)
Placebo
Placebo once daily for four weeks
干预措施: Placebo (Other)
结局指标
主要结局
Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline
时间窗: 4 weeks
次要结局
- Mean changes in Clinical COPD Questionnaire (CCQ) score from baseline(4 weeks)
- Mean changes in Modified Medical Research Council dyspnea scale (mMRC) from baseline(4 weeks)
- Mean changes in FEV1 from baseline(4 weeks)
- Mean changes in FVC from baseline(4 weeks)
- Mean changes in serum C-reactive protein (CRP) concentration from baseline(4 weeks)
- Evaluation of safety of study drug(4 weeks)