Comparative study of Oral Doxophylline along with Triple drug therapy versus Triple Drug Therapy in Stable Severe Chronic Obstructive Pulmonary Disease Patients A Randomised control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 1.Improvement in symptoms using Chronic obstructive pulmonary disease assessment test scoring scale.
研究概览
简要总结
Detailed informed consent will be obtained from from the eligible patients.Then the patients will be alloted to Group A or Group B by computer generated random number sequencing.Allocation concealment will be done by sequentially numbered ,opaque ,sealed envelopes.Group A patients will receive oral doxophylline sustained release 650 mg once along with triple drug therapy formoteral fumarate 4,8 mcg ,Glycopyrrolate 9 mcg and budesonide 160 mcg through metred dose inhaler or dry powder inhaler of equivalent dosage.Group B will receive only Formeterol fumarate 4.8 mcg ,Glycopyrrolate 9 mcg and budesonide 160 mcg through metered dose inhaler and dry powder inhaler of equivalent dosage.All participants will be followed up on 30 th ,60 th abd 90 th of the study.During every visit all participants will be assessed subjectively and objectively assessed .Adverse effects will be noted in each follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •At least 6 months of diagnosis of chronic obstructive pulmonary disease, according to GOLD guidelines.(Baseline post bronchodilator forced expiratory volume is less than 50% of predicted value.).
排除标准
- •.Patient with bronchial asthma, tuberculosis, lung tumour, bronchiectasis, pneumonia or other diseases that might affect pulmonary function or ventilation.
- •Patients with acute exacerbation of COPD.
- •3.Patients with congestive heart failure, unstable arrhythmias, chronic hypotension, active peptic ulcer disease, recent myocardial infarction and severe liver/kidney disease.
- •4.Patients who are unable to take Dry powder/Metered dose inhaler effectively even after adequate training.
结局指标
主要结局
1.Improvement in symptoms using Chronic obstructive pulmonary disease assessment test scoring scale.
时间窗: 3 months
2.Spirometry
时间窗: 3 months
3.Six minute walk test
时间窗: 3 months
次要结局
- Number of exacerbations(3 months)
研究者
Bhagiradhi Thimmapuram
SRM medical college hospital and research institute