NCT03110874已完成4 期
A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients With Partly Controlled Asthma
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 184 人开始时间: 2015年10月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 主要终点
- Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
研究概览
简要总结
A multi-center, randomized, open, non-inferiority, Phase 4 study
详细描述
A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients with Partly Controlled Asthma
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
- Single (Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult at the age of 19 or older.
- •Patient with partially controlled asthma (Asthma Control Test score 16~24)
- •Written informed consent to study participation.
排除标准
- •History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component.
- •Cardiac tachyarrhythmia.
- •contreated respiratory fungal, bacterial, or tuberculous infection.
- •Moderate to severe bronchiectasis
- •Planned use of the investigational product (Fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis*, or patients with chronic obstructive pulmonary disease requiring intensive treatment.
- •Asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings.
- •Asthma related emergency room visit or hospitalization within 2 weeks prior to screening.
- •Administration of systemic steroids within 2 weeks prior to screening.
- •Inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening.
- •Administration of systemic steroids within 2 weeks prior to screening.
- •Hypersensitivity reactions to lactose and milk.
- •Pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study.
- •Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once.
- •Participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study.
- •Individual considered by the he investigator to be inappropriate for study participation due to other reasons.
研究组 & 干预措施
Experimental group (one-way education)
Experimental
Experimental group (one-way education)
- Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
- video based education
干预措施: one-way education (Drug)
Control group(two-way education)
Active Comparator
Control group(two-way education)
- Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
- direct education
干预措施: two-way education (Drug)
结局指标
主要结局
Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
时间窗: Week 12
method of assessment:Forced expiratory volume
次要结局
- percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.(Week 4)
- Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.(Weeks 4 and 12)
- Change in inhaler technique score at Weeks 4 and 12 from baseline in each group(Weeks 4 and 12)
- Number of critical errors at Weeks 4 and 12 in each group.(Weeks 4 and 12)
- Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.(Weeks 4 and 12)
- Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).(Weeks 4 and 12)
- Adherence rate (%) at Weeks 4 and 12 in each group.(Weeks 4 and 12)
- Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.(baseline(day1),weeks 4 and weeks12)
研究者
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