A randomized, double blind, placebo controlled, prospective, multicentre, two arm, parallel study to assess efficacy, safety and tolerability of cough mixture of Levosalbutamol Sulphate 0.5 mg, Ambroxol Hydrochloride 15 mg and Guaiphenesin 50 mg per 5ml syrup in the symptomatic treatment of patients suffering from productive cough associated with acute bronchitis.

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 260 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1.Male or female >=18 to <60 years and willing to give their written informed consent.
•2.Patients with a recent onset of < or equal to 2 days of bronchial mucus production with impaired ability to cough up, and a baseline Bronchial Severity Score (BSS) of >=5 score points out of a maximum of 20 points
•3.Patients willing to comply with the protocol requirements.

•1.Pregnant or lactating women.
•2.Patient with known hypersensitivity to any of the components of the formulation.
•3.Female patients of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
•4.Patient with alcohol or drug dependence.
•5.Patient with a history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease.
•6.Patients with antibiotic use in the preceding 2 weeks
•7.Patients with a concurrent infection including Tuberculosis (TB) requiring antibiotic treatment.
•8.Patients with malignant growth or any severe somatopathic, neurologic and / or psychiatric disease.
•9.Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at screening and the results are deemed clinically significant by the investigator
•10.Patients who have participated in any clinical trial in the past 1 month

发起方

Glenmark Pharmaceuticals Ltd