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.
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Average change from baseline to end of trial in Forced expiratory volume in one second(FEV1).
研究概览
简要总结
This study is a randomized, open label, comparative, multi-centre trial comparing the safety and efficacy of Sustained release mucoregulator and Immediate release mucoregulator for 2 weeks in 200 patients with bronchial asthma that will be conducted in four centers in India only. The primary outcome measures will be evaluation of Average change in Forced expiratory volume in one second from baseline to end of treatment. The secondary outcomes will be evaluation Average change from baseline to end of trial in Forced expiratory vital capacity, Evaluation of auscultatory pattern, Average change from baseline to end of study in Symptom score of Cough, Difficulty in expectorating, Dyspnea, Cyanosis, Expectoration characteristic, Evaluation clinical global impression on severity (CGI-S) and clinical global impression on improvement (CGI-I). The anticipated date of enrollment will be 05th Jun 2010, subject to registration at CTRI. This is not a global trial.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •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 period5.Patients willing to give informed consent.
排除标准
- •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.
结局指标
主要结局
Average change from baseline to end of trial in Forced expiratory volume in one second(FEV1).
时间窗: Baseline Visit (day 0), week 2.
次要结局
- 1.Average change from baseline to end of trial in Forced expiratory vital capacity.(FVC)2.Evaluation of auscultatory pattern3.Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of ?Cough?Difficulty in expectorating?Dyspnea?Cyanosis4.Expectoration characteristic score?Viscosity of sputum ?Characteristic of sputum 5.Evaluation CGI-S and CGI-I(1.Baseline Visit (day 0), week 2.2.For CGI-I, at week 2 only.)