CTRI/2009/091/001041已完成3 期
?A CONTROLED LABELED, DOUBLE ARM, RANDOMIZED, MULTI- CENTRIC, PROSPECTIVE PHASE III CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM OF DIFFERENT ETIOLOGY?
Swiss Garnier Life SciencesNo. 68A, Vembuli Amman koli St, Alandur, Chennai 600016 .Phone : 044-22329837, 223128920 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients of either sex of age >= 18 and <= 70 years.
- •Patient suffering from mild to moderate bronchospasm of different etiology.
- •PEF between 50% to 80 % (mild to moderate)by using Peak flow meter.
- •Pre menopausal women must use the appropriate contraception.
- •Patient willing to give informed consent.
排除标准
- •Patients with significant pulmonary insufficiency, including both intrinsic lung disease and Respiratory failure i.e. severe bronchospasm
- •Patient with a history of known hypersensitivity from any one of the said medication.
- •Patients with acute myocardial infarction, hypotension.
- •Patients with uncontrolled hypertension.
- •Bronchospasm of anaphylactic, mechanical or cancerous origin.
- •Subjects with severe hepatic, renal failure or encephalopathy.
- •Chronic alcoholics.
- •Patients with history of cardiac surgery.
- •Pregnant & lactating women.
研究者
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