A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To assess the therapeutic effectiveness of Vilanterol/Fluticasone furoate with Formoterl/Budesonide by monitoring pulmonary function test (spirometry) FVC(L),%FVC,FEV1(L),%FEV1,FEV1/FVC,FEF25-75%
研究概览
简要总结
At present ,commonly used LABA ( long acting beta 2 agonist ) for asthma management require twice daily which is less convenient for patients and leads to reduced adherence with long term therapy whereas Vilanterol is a once daily therapy lead to improve adherence with long term therapy.Formoterol not highly selective in beta2 adrenoreceptor in lungs whereas vilanterol is highly selective for beta2 adrenoreceptor in lungs , in patients with asthma inhaled vilanterol produce significant increase in Forced Expiratory volume in 1s(FEV1). vilanterol /fluticasone furoate increase drug adherence to patients due to once daily administration. vilanterol/fluticasone cardioprotective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with stable bronchial asthma
- •patients who already receiving prescription with formoterol /budesonide.
排除标准
- •patients with asthma /copd overlap
- •patients with bronchiectasis
- •patients with allergic bronchopulmonary aspergillosis 4.history of smoking 5.pregnancy.
结局指标
主要结局
To assess the therapeutic effectiveness of Vilanterol/Fluticasone furoate with Formoterl/Budesonide by monitoring pulmonary function test (spirometry) FVC(L),%FVC,FEV1(L),%FEV1,FEV1/FVC,FEF25-75%
时间窗: In the initial ,patients FVC,%FVC ,FEV1,FEV1/FVC ,FEF25-75% will be evaluated ,mean changes in the parameters observed at 4th week,8th week ,12th week
次要结局
- Quality of Life assessed by ACQ5 Questionnaire,ACT Scores & Adherence Barrier Survey(6 months)
研究者
Dr .N .Nalini Jayanthi
SRM Medical college Hospital and Research Centre