EUCTR2009-011975-60-HU进行中（未招募）不适用
A multi-center, double-blind, placebo-controlled, parallel-group study to establishproof-of-concept and explore the efficacy of different doses of ACT-129968 in adultpatients with partly controlled asthma. - CONTRO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 412
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
- •- Males and females aged 18 to 65 years.
- •- Signed informed consent prior to any study-mandated procedure.
- •- Women of childbearing potential must use adequate contraception.
- •- Presenting with a diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines.
- •- Uncontrolled asthma while using only rescue medication as needed.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant or lactating women.
- •- Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced
- •- History of life-threatening asthma at any time, defined as an asthma episode that
- •required intubation and/or was associated with hypercapnia, respiratory arrest or
- •hypoxic seizures.
- •- Any asthma exacerbation requiring treatment with systemic corticosteroids within
- •the last 3 months.
- •- Any hospital admission for asthma within the last 6 months.
- •- Anti-IgE therapy (at any time).
- •- Ongoing or recent treatment with medication for allergic airway disease (either
- •prescribed or over-the-counter [OTC]) other than an inhaled beta2 agonist used
- •solely as reliever therapy on an ‘as-needed’ basis.
- •- Smoking within the last year, or life-time consumption of 10 pack-years e.g., 20 cigarettes/day for 10 years.
- •- Treatment with investigational asthma controller biological agents (recombinant
- •proteins or monoclonal antibodies) within 6 months prior to start of study drug.
研究者
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