CTRI/2010/091/000571
Not yet recruiting
Phase 3
Evaluation of Efficacy and Safety of a Sustained release vs. Immediate release Mucoregulator for the treatment of bronchial asthma: An open label, randomized, comparative, multi-centric trial.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sun Pharmaceutical Industries Ltd.
- Enrollment
- 200
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female Patients aged between 18 and 65 years.
- •2\.Patients with history of bronchial asthma and chronic obstructive pulmonary disease as defined by American Thoracic Society (ATS).
- •3\.Baseline FEV1 50 ? 85% in patients either untreated or receiving e.g. short\-acting bronchodilators.
- •4\.No change in the asthma treatment 4 weeks prior to baseline period
- •5\.Patients willing to give informed consent.
Exclusion Criteria
- •1\.Pregnant or lactating women and women of childbearing potential who are not using contraceptives.
- •2\.Patients with infection of lower airways.
- •3\.Patients with cancer, pulmonary tuberculosis, or acute infection, Myocardial infarction, low blood pressure.
- •4\.Patients who were hospitalized for asthma within three month before the study.
- •5\.Patients suffering from lung disease other than asthma and COPD.
- •6\.Patients who had used systemic steroid prior to 4 week of baseline visit and who are taking long acting \&\#946;\-agonist, inhaled anticholinergics with in one month before study and cromolyn, nedocromil within two week before study.
- •7\.Patients who were heavy smokers with \> 10 pack\-years.
- •8\.Patients with any severe illness like liver insufficiency, active hepatitis, known infection with HIV etc.
- •9\.Patients with history of non\-compliance to medical regimens or those patients unwilling to comply with the study protocol.
- •10\.Patients with suspected hypersensitivity and/or contraindication to any ingredients of the study medication or rescue medications.
Outcomes
Primary Outcomes
Not specified
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