A randomized double blind parallel group comparative study to evaluate efficacy and safety of triplet combination (Ciclosonide, Tiotropium bromide and Formoterol) and dual combination (Tiotropium bromide and Formoterol) in mild to moderate cases of Chronic Obstructive Pulmonary Disease

Research project grant of Government of Gujarat1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2011年1月13日最近更新: 2019年11月18日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 60
试验地点: 1
主要终点: Pulmonary function test (FEV1 and FVC)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

There will be 70 patients in the study. This is randomized, double blind, active control, parallel group, single centre, study to evaluate efficacy and safety of triplet combination (Ciclosonide, Tiotropium bromide and Formoterol) and dual combination (Tiotropium bromide and Formoterol) in mild to moderate cases of Chronic Obstructive Pulmonary Disease. It will be done in India. Primary outcome measures will be pulmonary function test (FEV1 and FVC) at one month interval for three months.Secondary outcome measures will be exercise tolerance (Six minute walk distance) at one month interval for three months.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 35.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Age between 35 to 70 years of either sex Clinically diagnosed mild to moderate COPD as per GOLD guideline (FEV1 more than 50 FEV1 and FVC ratio less than 0.7) Ability to give written informed consent Smokers and ex-smokers more and equal to 10 pack per years.

排除标准

•Patients on oral steroid History Of significant illness of other system especially cardiovascular system History of exacerbation in run in period Patients having other serious respiratory illness ( tuberculosis asthma) other than COPD History of long acting antihistaminic within 1 week History of Hypersensitivity to study medications Contraindication to six minute walk test Do not give informed consent.

结局指标

主要结局

Pulmonary function test (FEV1 and FVC)

时间窗: Prospective

次要结局

Six minute walk distance (6MWD)(Prospective)

研究者

发起方

Research project grant of Government of Gujarat

申办方类型

Government funding agency

研究点 (1)

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