Inhaled Fenotereol,Ipratroium Plus Beclomethasone Versus Salmeterol,Tiotropium Plus Fluticasone in Frequent Excerbator COPD Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- to assess improvement of symptoms mainly dyspnea
研究概览
简要总结
Chronic obstructive pulmonary disease is heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive ,airflow obstruction.
There are network meta analysis to compare the efficacy and safety of short acting bronchodilators Vs long acting agents in treatment of COPD
详细描述
Aim of the work1.To compare efficacy of short acting beta 2 agonists ,short acting antimuscrinic agents and beclomethasone versus long acting beta 2 agonist,short acting antimuscurnic agents and fluticasone.- Type of the study: This study is a randomized controlled trail 2.4. 2- Study Setting: Present study will be conducted in chest outpatient clinic Chest department Assiut University hospital 2.4. 3- Study subjects: Frequent exacerbator COPD patients Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group).
Main outcome variable is difference in dyspnoea scores in frequent exacerbator COPD patients receiving long-acting steroids vs. short acting treatment. Based on previous systematic review we expected to find significant improvement in long-acting treatment group (large effect size). Data will be collected through: patients diagnosed COPD by different investigations (history, examinations spirometry) have recurrent exacerbations, some patients receiving short acting beta 2 agonists, short acting anti-muscurnic agents and beclomethasone versus long acting agents and fluticasone then all patients followed using dyspnea scores, CCQ, saint George questionnaire which assess heath related quality of life.
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
- None
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
- •All frequent exacerabator copd patients
排除标准
- •patients less than 18
研究组 & 干预措施
SABA,SAMA ICS
干预措施: SABA SAMA ICS Vs LABA LAMA ICs (Drug)
LABA,LAMA ICS
干预措施: SABA SAMA ICS Vs LABA LAMA ICs (Drug)
结局指标
主要结局
to assess improvement of symptoms mainly dyspnea
时间窗: 1 year
to assess dyspnea in two groups by mMRC,saint gorge quetsonaire
次要结局
未报告次要终点
研究者
Nermen Abuelkassem
lecturer
Assiut University
