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.

Sun Pharmaceutical Industries Ltd.0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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 β-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.

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