Comparative Study Between Three Therapeutic Options for Treatment of Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- FEV1 value
研究概览
简要总结
Forty five COPD patients will be recruited from Chest Disease Department, Tanta University Hospital, Tanta, Egypt.
The aim of the study is to Compare between the effectiveness of three therapeutic options for treatment of moderate and severe COPD patients .These therapeutic options include Inhaled corticosteroid (ICS) plus long acting B2-agonist (LABA) combination, Inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) combination and Long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC) combination .
详细描述
This study will be prospective randomized double blind study.
The forty five COPD patients will be divided into three groups:
Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).
Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).
Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).
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)
盲法说明
double blind
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 30 to 40 years or older.
- •Patient with 30%≥ FEV1<80% predicted and FEV1/FVC <70% predicted.
排除标准
- •Patients with FEV1< 30% predicted or FEV1< 50% predicted plus chronic respiratory failure.
- •Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
- •Patients with history of asthma.
- •Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.
研究组 & 干预措施
Group 1
Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination (160/4.5mcg) 2 inhalations bid).
干预措施: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid (Drug)
Group 2
Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg inhaled capsule once daily+ Budesonide inhalation 200 mcg twice daily).
干预措施: Tiotropium 18 mcg capsule inhaled once daily + Budesonide (Drug)
Group 3
Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC). (Tiotropium 18 mcg inhaled capsule once daily+ Formoterol 12 mcg inhaled capsule twice daily)
干预措施: Formoterol/Tiotropium (Drug)
结局指标
主要结局
FEV1 value
时间窗: three months
Forced expiratory volume in 1second (FEV1) value
Tumer necrosis factor alpha ( TNF )
时间窗: three months
serum level
Interlukin 6 ( IL6 )
时间窗: three months
serum level
Fibrinogen
时间窗: Three months
serum level
次要结局
未报告次要终点
研究者
Dr. Tarek Mohamed Mostafa
Associate Professor
Tanta University