EUCTR2018-001704-10-NL进行中（未招募）1 期
A Randomized, Double-blind, Two Treatment, Two Period, Chronic dosing (4 weeks), Crossover,Multi-center Pilot study to evaluate the effects of Budesonide/Glycopyrronium/FormoterolFumarate and Glycopyrronium/Formoterol Fumarate on Specific Image based AirwayVolumes and Resistance in Subjects with Moderate to Severe Chronic Obstructive PulmonaryDisease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •-Subject must be 40 years to =80 years of age inclusive, at the time of signing the
- •informed consent form at Visit 1.
- •-COPD Diagnosis: Subjects with an established clinical history of COPD
- •-Screening clinical laboratory tests must be acceptable to the Investigator.
- •-Screening ECG must be acceptable to the Investigator
- •-Individual Compliance: Subjects must be willing to remain at the study center as required
- •per protocol to complete all visit assessments
- •-Patients should be on scheduled maintenance treatment with one or more inhaled
- •bronchodilator therapies.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •-As judged by the investigator, any evidence of significant diseases other than COPD, i.e.,
- •disease or condition which, in the investigator’s opinion makes it undesirable
- •for the subject to participate in the trial.
- •-Spirometry Performance:
- •1) Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
- •2) Repeatability: Subjects who cannot perform technically acceptable spirometry in accordance with ATS repeatability criteria
- •-Cancer: Subjects who have cancer that has not been in complete remission for at least five
- •-Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse
- •alcohol or drugs
- •-Subjects who in the opinion of the investigator are unable to abstain from prohibited medications including LABA/LAMAs/ICS
研究者
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