Assessment of Efficacy, Safety and Tolerability of therapy with fixed dose combination (FDC) of Cetirizine with Ambroxol and Ambroxol as monotherapy in the treatment of productive Cough: An Open-label, Prospective, Multi-centre, Observational Study

Dr Reddys laboratories Ltd5 个研究点分布在 1 个国家目标入组 250 人开始时间: 2015年4月20日最近更新: 2015年9月17日

试验速览

阶段: 不适用
状态: 已完成
发起方: Dr Reddys laboratories Ltd
入组人数: 250
试验地点: 5
主要终点: 1.Total Symptom Score (TSS) for cough would be sum total of four scores given below:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study Title - Assessment of Efficacy, Safety and Tolerability of therapy with fixed dose combination FDC of Cetirizine with Ambroxol and Ambroxol as monotherapy in the treatment of productive Cough: An Open-label, Prospective, Multi-centre, Observational Study

Research Objectives -

To assess the efficacy of therapy with fixed dose (FDC) combination of Cetirizine 5 mg plus Ambroxol 30 mg, and Ambroxol 30 mg monotherapy in controlling the symptoms of productive cough.
To assess the safety and tolerability of therapy with fixed dose (FDC) combination of Cetirizine 5 mg plus Ambroxol 30 mg, and Ambroxol 30 mg monotherapy in controlling the symptoms of productive cough.

Inclusion criteria:

Children between over 6 to 18 years of age
Male and female children
Children having productive cough (cough withexpectoration) associated with any of the nasal symptoms (nasal discharge, nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours
Child willing to provide assent and parents/guardian willing to provide written informed consent
Child requiring therapy with fixed dose FDC combination

of Cetirizine 5 mg with Ambroxol 30 mg, OR Ambroxol 30 mg monotherapy as per the clinicianâ€™s discretion

Willing and able to understand and comply with all study requirements

Exclusion criteria:

Use of any throat lozenge, throat spray, cough drop,

menthol-containing product, or any product with demulcent

properties within last 8 hours

Use of any "cold medication" (e.g. nasal or systemic

decongestants, antihistamine, expectorant, anti-tussive)

within last 8 hours

Severe cough requiring hospitalization
Presence of fever within last 8 hours
Active pulmonary disease such as bronchopneumonia,

bronchial asthma or tuberculosis

Known allergy to and/or hypersensitivity to ambroxol

and/or cetirizine

Any other condition, which in the opinion of the

clinician/investigator, could interfere significantly with the

treatment and assessment process

Use of any investigational therapy within 30 days prior to randomization
Child not willing to provide assent and parents/guardian not willing to provide written consent.

研究设计

研究类型: Observational

入排标准

年龄范围: 6.00 Year(s) 至 18.00 Year(s)（—）
性别: All

入选标准

•Children between over 6 to 18 years of age
•Male and female children
•Children having productive cough (cough with expectoration) associated with any of the nasal symptoms (nasal discharge, nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours
•Child willing to provide assent and parents/guardian willing to provide written informed consent
•Willing and able to understand and comply with all study requirements.

排除标准

•1.Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 8 hours 2.Use of any "cold medication" (e.g. nasal or systemic decongestants, antihistamine, expectorant, anti-tussive) within last 8 hours 3.Severe cough requiring hospitalization 4.Presence of fever within last 8 hours 5.Active pulmonary disease such as bronchopneumonia, bronchial asthma or tuberculosis 6.Known allergy to and/or hypersensitivity to ambroxol and/or cetirizine 7.Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process 8.Use of any investigational therapy within 30 days prior to randomization 9.Child not willing to provide assent and parents/guardian not willing to provide written informed consent.