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临床试验/NCT05748977
NCT05748977尚未招募早期 1 期

Inhaled Fenotereol,Ipratroium Plus Beclomethasone Versus Salmeterol,Tiotropium Plus Fluticasone in Frequent Excerbator COPD Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月20日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: SABA SAMA ICS Vs LABA LAMA ICs (Drug)

LABA,LAMA ICS

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nermen Abuelkassem

lecturer

Assiut University

研究点 (1)

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