EUCTR2019-000795-41-PL进行中（未招募）1 期
A PHASE IIa, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF MTPS9579A IN PATIENTS WITH ASTHMA REQUIRING INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
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
- •- Ability to comply with the study protocol, in the investigator's judgment
- •- Age 18-75 years
- •- Body mass index of 18-38 kg/m2 and weight >= 40 kg at screening
- •- Documented physician-diagnosed asthma
- •- Pre-bronchodilator FEV1 40%-80% predicted at screening
- •- On inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
- •- Documented history of >= 2 asthma exacerbations within the 12
- •months prior to screening while on daily ICS maintenance therapy
- •- Use of contraceptive measures
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •- Diagnosis of mimics of asthma or significant respiratory disease other than asthma
- •- Recent history of smoking
- •- Pregnant, lactating, or intending to become pregnant during the study or within 60 days after the last dose of the investigational medical product
- •- Comorbid conditions that may interfere with the evaluation of an investigational medical product
- •- Known sensitivity to any of the active substances or their excipients to be administered during dosing
- •- History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
- •- Asthma exacerbation within 4 weeks prior to screening
- •The above information is not intended to contain all considerations relevant to a patient’s participation in this clinical trial.
研究者
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