A clinical trial to study the effect of cough mixture syrup of levosalbutamol, ambroxol and guaiphenesin in the treatment of patients suffering from productive cough associated with acute bronchitis.
- Conditions
- Health Condition 1: null- Productive Cough Associated with Acute Bronchitis
- Registration Number
- CTRI/2012/03/002477
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 260
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ease of Cough and Clearance of SputumTimepoint: 8-days
- Secondary Outcome Measures
Name Time Method 1.Improvement in BreathlessnessTimepoint: 8-days;2.Reduction in Sputum VolumeTimepoint: 8-days;3.Decrease in Consistency of SputumTimepoint: 8-days;4.Change in mean Bronchial Severity ScoreTimepoint: 8-days;5.Change in Patientâ??s General Well beingTimepoint: 8-days