EUCTR2011-003997-10-HU进行中（未招募）不适用
A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND DOSING REGIMENS OF MEMP1972A IN ADULTS WITH ALLERGIC ASTHMA WHO ARE INADEQUATELYCONTROLLED ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER (COSTA) - COSTA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 560
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
- •- Age 18-75 years
- •- Body weight = 40 kg
- •- Normal CXR
- •- Diagnosis of asthma for at least 12 months
- •- Evidence of documented bronchodilator reversibility
- •- Prebronchodilator FEV1 = 40% and = 80% predicted
- •- Daily use of ICS and second controller for a minimum of 3 consecutive months prior to screen
- •- History of at least one protocol-defined asthma exacerbation in the 18 months prior to screen
- •- Inadequately controlled asthma despite compliance with asthma controller therapy documented by daily diary and ACQ
- •- Positive aeroallergen-specific IgE OR a total serum IgE = 75 IU/mL
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Asthma exacerbation requiring systemic steroids in the 30 days prior to randomization
- •- Have pre-existing active lung disease other than asthma
- •- Any infection including chronic or latent infections or infections requiring treatment during screening
- •- Clinically significant medical disease that is uncontrolled despite treatment
- •- Any condition that contraindicates the use of an investigational drug
- •- History of significant exposure to water-borne parasites and/or have recent diarrheal illness of indeterminate etiology
- •- Former smoker with >10 pack year history or current smoker
- •- History of anaphylaxis or allergic reaction during the use of a monoclonal antibody
- •- Use of any excluded concomitant therapies
- •- Men and women who are not willing to use highly effective method of contraception
- •- Women who are pregnant or lactating
研究者
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