Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease : a Randomized Crossover Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.
The main questions it aims to answer are:
- Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?
- What medical problems do participants experience when taking doxofylline and procaterol?"
详细描述
This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease were included. Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug. Respiratory symptoms were assessed by modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary functions were assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) were also collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)
- •Aged 40 years or older
- •Smoking 10 pack-years or more
- •Postbronchodilator FEV1 < 80%
排除标准
- •History of COPD exacerbation within 3 months
- •Oral or intravenous corticosteroid treatment within 6 weeks
- •Oral bronchodilators e.g. doxofylline, theophylline, procaterol, or salbutamol within 1 week before randomization
- •Tracheostomy, invasive or noninvasive mechanical ventilation
- •Inability to perform spirometry or 6-minute walk test
- •Pregnant or breastfeeding women
研究组 & 干预措施
Doxofylline arm
Doxofylline 400 mg oral twice daily for 4 weeks
干预措施: Doxofylline (Drug)
Procaterol arm
Procaterol 50 mcg oral twice daily for 4 weeks
干预措施: Procaterol (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1)
时间窗: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Postbronchodilator FEV1
Forced vital capacity (FVC)
时间窗: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Postbronchodilator FVC
Forced expiratory flow at 25-75% of FVC (FEF25-75)
时间窗: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Postbronchodilator FEF25-75
次要结局
- modified Medical Research Council (mMRC) score(At the day of randomization (week 0), week 4, week 6, and week 8 of the study)
- COPD Assessment Test (CAT)(At the day of randomization (week 0), week 4, week 6, and week 8 of the study)
研究者
Narongkorn Saiphoklang, MD
Associate Professor
Thammasat University