Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Long term effect of FF/VI
研究概览
简要总结
Exercise induced asthma (EIA) is common in adolescents. (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Adolescent asthmatics were referred for evaluation of EIA. Patients with a positive exercise challenge test, were allocated to a single administration of salbutamol and 22 to FF/VI in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.
详细描述
Exercise induced asthma (EIA) is common in adolescents. Relvar® (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of EIA. 44 patients had a positive exercise challenge test (ECT), 22 (22/44) were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose.
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
- Double (Participant, Investigator)
盲法说明
Medications and placebos were provided by the hospital pharmacy and medications were given by the nurse. Randomization was generated by computer, independently of trial staff as described (Salbutamol inhaler + Ellipta placebo or FF/VI + placebo Salbutamol inhaler). Technicians performing the ECT, investigators and patients were blinded to treatment choice
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent asthmatics aged 12-18 years
- •Symptoms of shortness of breath on exercise and asthmatics before entry to military service
- •Referral for evaluation of exercise challenge test
排除标准
- •Baseline FEV1<65% before exercise test
- •Acute illness
- •History of intolerance to beta agonists
- •Use of the following medications prior to the study was restricted: inhaled corticosteroids or Montelukast (2 weeks), systemic steroids (2 months) and bronchodilators (24 hours)
研究组 & 干预措施
Salbutamol
Salbutamol (Salbutrim, Trima) inhaler (400 µg) via spacer + Relvar® Ellipta placebo
干预措施: Salbutamol (Drug)
FF/VI
Placebo Salbutamol inhaler + Relvar® Ellipta (92/22 µg, GSK, UK)
干预措施: Fluticasone furoate (FF)/Vilanterol (VI) (Drug)
结局指标
主要结局
Long term effect of FF/VI
时间窗: 30-60 days
Exercise challenge test following FF/VI treatment
次要结局
- Short term effect of FF/VI(15 minutes)
研究者
l_bentur
Prof. Lea Bentur
Rambam Health Care Campus