Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety & efficacy data of Acebrophylline + Acetylcysteine tablet
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The aim of this prescriber based post marketing surveillance is to assess efficacy of Acebrophylline + Acetylcysteine in the actual field conditions of use.
研究概览
简要总结
Coughs are usually caused by respiratory infections, including colds or influenza, the most common
causes of coughs; bronchitis, an inflammation of the mucous membranes of the bronchial tubes
Coughs are usually caused by respiratory infections, including colds or influenza, the most common
causes of coughs; bronchitis, an inflammation of the mucous membranes of the bronchial tubes.
The aim of this prescriber based post marketing surveillance is to assess efficacy & safety of Acebrophylline + Acetylcysteine in the actual field conditions of use.
All patients clinically manifesting with symptoms of COPD and who have been prescribed
Adverse event reporting will be done using PMS form supplied by Medical Representative. Patients
will be questioned about any adverse experience during the treatment period (Both anticipated and
unexpected side effects)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex of age 18 to 60 years [both inclusive]
- •Willing to give written informed consent
- •All patients clinically manifesting with symptoms of Chronic obstructive pulmonary disease (COPD).
排除标准
- •Patients known, or thought to be hypersensitivity to study drug 2) History of auto-immune disease 3) Concurrent use of corticosteroids 4) Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion 5) Participation in other clinical trials the last three months and during study participation 6) Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs 7) Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 8) Patients with galactose or fructose intolerance 9) Patients with severe renal impairment, including those receiving dialysis.
- •Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
- •Patients with preexisting gallbladder disease 12) Active peptic ulcer disease.
结局指标
主要结局
The aim of this prescriber based post marketing surveillance is to assess efficacy of Acebrophylline + Acetylcysteine in the actual field conditions of use.
时间窗: 4 weeks from base line and at 8 weeks
次要结局
- The aim of this prescriber based post marketing surveillance is to assess safety of Acebrophylline plus Acetylcysteine in the actual field conditions of use.(2 weeks)