?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?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- To compare efficacy of the FDC of Doxophylline 800 mg SR and Montelukast 10 mg against Doxophylline 800 mg SR in subjects suffering with acute bronchospasm of different etiology.
研究概览
简要总结
The study will be conducted after obtaining written informed consent from subjects. Subjects will go through medical screening during pre-enrollment visit (Visit 1). Screening will include complete clinical evaluation (Demographic data, physical examination, clinical symptoms). All demographic data and other symptoms will be recorded in the case report form. Routine haematological examinations like Hb, TLC, DLC, hepatic functions (SGOT, SGPT), renal functions (serum Creatinine, serum uric acid) and baseline PEF by using Peak Flow meter will be done on screening. Urine pregnancy test will be done in female subjects of the age of child bearing capability at the start of the therapy. Subjects who met the eligibility criteria will be enrolled into the study. On visit 2 first dose of drug will be administered & remaining doses will subject diary for self assessment of quality of life by using ADL Scale. Follow up will be done for subsequent visits (Day 4, Day 7 and Day 10) with efficacy evaluation (PEF by using Peak Flow meter) and safety & tolerability parameters will be evaluated. On completion of therapy all lab parameters will be repeated again.However, patients will be allowed to visit the investigator at time points other than specified in the protocol in case of any adverse event or depending upon the discretion of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
To compare efficacy of the FDC of Doxophylline 800 mg SR and Montelukast 10 mg against Doxophylline 800 mg SR in subjects suffering with acute bronchospasm of different etiology.
时间窗: 10 DAYS
次要结局
- To compare the safety & tolerability of FDC of Doxophylline 800 mg SR andMontelukast 10 mg against Doxophylline 800 mg SR on oral administration in subjects suffering with acute bronchospasm of different etiology(10 DAYS)