CTRI/2013/03/003504已完成3 期
A Multi-centric, Double blind, Randomized, Comparative Clinical trial to Evaluate the Efficacy and Safety of Seratrodast in the treatment of Asthma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Proportion of patients showing an improvement in the severity of asthma clinical symptoms
研究概览
简要总结
The study is a prospective �A Multi-Centric, Double Blind, Randomized, Comparative Clinical Trail to Evaluate the Efficacy and Safety of Seratrodast in the treatment of Asthma�. In this study we have to generate data for 200 subjects across four sites in two months of recruitment period. We identified the sites on the basis of their medical specialty and relevant experience, type of Institute and its geographic location, paramedical staff, Investigator’s qualifications and their availability for the entire duration of the study, and most importantly their recruitment rate. These identified sites comprise of both private institutions as well as government institutions to recruit patients from all economical sets.xml:namespace prefix = o /
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Non-smoking male or female patients between 18 and 65 years of age.
- •2 Patients with active bronchial asthma, of mild to moderate severity, as defined by the National Asthma Education and Prevention Program.
- •aFEV1 60% of predicted normal value.
- •c.FEV1 and PEF requirements of items a and b are achieved with the lowest dose of an inhaled steroid as monotherapy.
- •Patients should be expectorating sputum of 20 g/d for at least 2 weeks prior to study.
- •Patients willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •1 Patients with a known history of hypersensitivity to study medications 2 Patients receiving a course of oral or inhaled high dose corticosteroids or any other anti inflammatory drugs such as sodium cromoglycate or nedocromil sodium during the previous 4 weeks 3 Patients receiving either a short acting or a long acting beta2 agonists either as monotherapy inhaler puffs or in combination with an corticosteroid as inhaler puffs 4 Patients receiving a course of antibiotics or mucolytic agents during the previous 4 weeks 5 Patients showing evidences of pulmonary infection on chest radiograph and sputum bacteriology bacteria more than 107 per mL 6 Females that are pregnant breast-feeding or not using birth control and are sexually active 7 Serious systemic disorders incompatible with the study either acute or chronic affecting any other target organ in the human body 8 Patients with history of poorly controlled associated disease such as: heart disease thyroid disorders coagulation disorders and hematologic problems etc.
- •9 Historyof cancer 10 Patients who are otherwise judged inappropriate for inclusion in the study by the investigator.
结局指标
主要结局
Proportion of patients showing an improvement in the severity of asthma clinical symptoms
时间窗: Proportion of patients showing an improvement in the severity of asthma clinical symptoms
次要结局
- Mean change from baseline in the various lung function parameters(4 Week)
- Mean change from baseline in the muco ciliary clearance(4 Week)
- Proportion of patients with adverse events associated to the drug(4 Week)
- Mean change from baseline in the sputum parameters quantity viscolasticity and eiosinophil cationic protein(4 Week)
研究者
研究点 (3)
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