A Pilot Randomised Controlled Superiority Trial of Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of asthma exacerbations
研究概览
简要总结
Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care
详细描述
single centre randomised control trial with the aim of comparing the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study there is random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol daily single dose for the relief of symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 18 and 75 years old with a diagnosis of mild asthma attending the participating primary health care centres in Bahrain, being managed with usual care (SABA or ICS and SABA combination) and no other medications
排除标准
- •Health centre medical record or self-reported use of LABA, leukotriene receptor agonist, theophylline, anticholinergic agent, oral corticosteroids for regular maintenance therapy in 3 months before entry to the trial. [NB. nasal corticosteroid is permitted
研究组 & 干预措施
standard of care
Short acting beta agonist or inhaled corticosteroids
干预措施: Standard Preparation (Drug)
fluticasone-vilanterol
LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid
干预措施: fluticasone-vilanterol (Drug)
结局指标
主要结局
Number of asthma exacerbations
时间窗: 32 weeks/8 months
measured by asking the participants about Hospital admission with asthma/ Visit to ED with Asthma and receiving treatment with nebulizer and/ or any corticosteroids (IV, IM, PO or neb)/ Home use of nebulizer and/or corticosteroids (IV, IM, oral or nebulized). treatment with nebulizer and/ or any corticosteroids (IV, IM, PO or neb)/ Home use of nebulizer and/or corticosteroids (IV, IM, oral or nebulized)
Change in Asthma Control Score
时间窗: baseline, 8 months
measured by the 7 item asthma control questionnaire. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
次要结局
- Change in Asthma Quality of life score(baseline, 8 months)
研究者
Dr Ghufran Jassim
Associate professor
Royal College of Surgeons in Ireland - Medical University of Bahrain