EUCTR2017-000735-14-PL进行中（未招募）1 期
The efficacy and safety of new formulation of combination of fluticasone propionate / salmeterol (125µg / 25µg) in MDI HFA inhaler compared with the reference drug at a dose of 500µg / 50µg in DPI (dry powder inhaler) type disc in patients with chronic asthma - COMBO-Study
ek-Am Sp. z o.o.0 个研究点目标入组 231 人开始时间: 2017年10月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 231
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female, age 18-70
- •2. Asthma diagnosed min 3 months before the screening visit. Therapy minimal requirement - GINA grade 4
- •3. FEV1 elevation by at least 12% and min. 200 ml after 400 µg of salbutamol application noted at the screening
- •4. FEV1 50-85% of predicted at the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Severe life threatening asthma or hospitalisation due to asthma exacerbation during 3 months before the screening
- •2. Uncontrolled or untreated significant immunology, endocrinology, hematology, psychiatric, neurology, hepatic, gastrointestinal disorders or neoplasma
- •3. Heart arythmia or other cardiovascular disorders, including hypertension with DBP = 95 mm Hg
- •4. Antibiotics taken during last 8 weeks before screening due to respiratory infection
- •5. Smoking >10 cigarettes/day
研究者
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