A Phase IV , Randomized, Open Label, multicentre study to confirm the safety and tolerability of Alerfix Total (Levocetirizine, Montelukast, Ambroxol) in patients with Non specific respiratory symptoms (NSRS) with Asthma.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- To explore the overall safety profile of Alerfix total, as measured by adverse events and Questionnaires, in patients with NSRS and asthma under conditions of routine medical practice.
研究概览
简要总结
This is Randomized, Open Label and multicentre study, designed to evaluate the efficacy and safety of study drug Alerfix Total.
This study will include patients with NSRS with asthma by their treating physician in accordance with the respective local prescribing information and routine clinical practice
The patients treated with Alerfix Total will be followed for assessment of safety parameters throughout the study (2 weeks).
Visual analog scale scores will be assessed at baseline (Day 1 before the treatment), day 7 and at end of the treatment (day 14).Quality of life will be assessed at baseline (Day 1 before the treatment), day 7 and at end of the treatment (day 14). Adverse events will be recorded throughout the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Men or Women, between 18 to 80 years of age (both inclusive).
- •2.The patient experiencing Cough and/or wheeze and/or chronic dyspnoea or any other symptoms of NSRS with asthma 3.Patient indication and disease condition according to the “INDICATION & USAGE†as mentioned in the package insert available with Alerfix Total 4.Women of childbearing potential using an acceptable method of birth control.
- •5.Willing to give written informed consent for participation in the study and to comply with the study procedures.
排除标准
- •1.Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN) 2.Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl) 3.Pregnancy 4.Malignancy 5.Contraindication as mentioned in package insert 6.Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study 7.Patients with known history of hypersensitivity to the study drug.
结局指标
主要结局
To explore the overall safety profile of Alerfix total, as measured by adverse events and Questionnaires, in patients with NSRS and asthma under conditions of routine medical practice.
时间窗: Not Applicable
次要结局
- Not Applicable(Not Applicable)