NCT00842270已完成2 期
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
AB Science0 个研究点目标入组 44 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- decrease in oral corticosteroid therapy (weaning extent)
研究概览
简要总结
The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on :
- the decrease in corticosteroid therapy
- the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function)
- the pharmacokinetic profile of AB1010
- clinical and biological safety parameters
详细描述
This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day.
The study treatment is administered for 16 weeks:
- the first 4 weeks are a run-in period during which corticosteroids remain stable;
- during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs;
- the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
- •Disease duration > 1 year.
- •Stable disease with no exacerbation episode for at least one month before inclusion.
- •Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months.
- •Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone.
排除标准
- •Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
- •History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.
研究组 & 干预措施
2
Experimental
4,5 mg/kg/day
干预措施: AB1010 (Drug)
3
Experimental
6 mg/kg/day
干预措施: AB1010 (Drug)
4
Placebo Comparator
matching placebo for AB1010 3, 4,5 and 6 mg/kg/day
干预措施: placebo (Drug)
1
Experimental
AB1010 3 mg/kg/day
干预措施: AB1010 (Drug)
结局指标
主要结局
decrease in oral corticosteroid therapy (weaning extent)
时间窗: 16 weeks
次要结局
- asthma exacerbation rate(16 weeks)
- asthma control improvement(16 weeks)
研究者
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