A randomized controlled trial to compare safety and efficacy of inhalational long acting β2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate in adult patients with reversible obstructive airway disease.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare efficacy of once daily VI/FF against twice daily SAL/FF in adult patients with chronic obstructive airway disease.
研究概览
简要总结
This research basically addresses the pressing need for optimized treatment strategies amidst increasing respiratory ailments. This is a comparative study between inhalational long acting β2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate for safety and efficacy. Out of the two Vilanterol being once a daily drug has better adherence to regimen and so we developed the proforma for obtaining the information regarding the safety and efficacy of the drugs in adult patients at the end of 18 months study period. Adult patients (age group 18-60 year) suffering from reversible obstructive airway disease would be selected from pulmonary medicine department of a tertiary care center and would be divided into two groups of 35 patients each and one group will receive Vilanterol with fluticasone furoate while the other will receive Salmeterol with fluticasone furoate and they will be accessed for changes in FEV1 and FVC values , severity and numbers of respiratory distress and AQI thrice at beginning, at 7 day interval and finally at 4 week interval.
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
- •Age: 18 – 60 years of age.
- •Clinically diagnosed patients of chronic obstructive airway disease with FEV 1 between 40% to 85% of the predicted normal value.
排除标准
- •Acute exacerbations of asthma.
结局指标
主要结局
To compare efficacy of once daily VI/FF against twice daily SAL/FF in adult patients with chronic obstructive airway disease.
时间窗: At Baseline then at 7 days and then at end of 4 Weeks
次要结局
- 1. To assess the safety & tolerability of FF/VI compared to FP/SAL by analyzing adverse events, serious adverse events during 4 weeks.
研究者
Dr Chandra Dhar Shukla
Bharati Vidyapeeth (DTU) Medical College Pune
