A clinical trial to compare the evaluation of efficacy, safety and tolerability of three expectorants in the treatment of productive cough associated with acute bronchitis, AECB, pneumonia and asthmatic bronchitis in Indian populatio
- Registration Number
- CTRI/2009/091/000112
- Lead Sponsor
- Glenmark Pharmaceuticals LtdBD Sawant Marg, Chakala, Off. Western Express Highway, Andheri (E), Mumbai 400 099
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 354
1.Patients of either sex 18-65 years
2.Subjects giving written informed consent
3.Patients with Productive Cough associated with Acute Bronchitis, AECB, Pneumonia and Asthmatic Bronchitis
4.In the opinion of the investigator, able to comply with the requirements of the protocol.
1.Patients with Cystic Fibrosis
2.Patients with Active Tuberculosis
3.Patients with lung cancer or lung metastasis
4.Patients with severe bronchiectasis
5.Patients with acute respiratory decompensation
6.Patients with Chronic respiratory insufficiency associated with resting hypoxemia,
7.Patients requiring hospitalization for parenteral antibiotic treatment
8.Patients with hypersensitivity against the medication under study
9.Patients with Female patients with child bearing potential-
Who are pregnant
Who are breastfeeding
Who are not practicing acceptable methods of birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in consistency of sputum between the test and reference drugsTimepoint: End of study
- Secondary Outcome Measures
Name Time Method To compare the change in volume of sputum, frequency and severity of cough, breathlessness from baseline and between the groups.Timepoint: End of study