NCT01225315已完成2 期
A Multi-center, Double-blind, Placebo-controlled, Parallel-group Study to Establish Proof-of-concept and Explore the Efficacy of Different Doses of ACT-129968 in Adult Patients With Partly Controlled Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 97
- 主要终点
- To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
研究概览
简要总结
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure
- •Males and females age 18 to 65 years
- •Women of childbearing potential must use adequate contraception
- •Presenting with a diagnosis of asthma according to GINA Guidelines
- •Pre-bronchodilator forced expiratory volume in one second (FEV1) < / = 85% of patient's predicted normal value
- •Reversibility of airway obstruction of > / = 12% and > / = 200mL from pre-bronchodilator FEV1
- •ACQ score > / = 1.5
排除标准
- •History of life-threatening asthma
- •Any asthma exacerbation requiring treatment with systemic corticosteroids within the last 3 months
- •Ongoing or recent treatment with medication for allergic airway disease
- •Smoking within the last year, or life-time consumption > / = 10 pack-years (e.g., 20 cigarettes/day for 10 years)
- •History of chronic pulmonary disease (other than asthma), such as chronic obstructive pulmonary disease (COPD), fibrosis, tuberculosis or sarcoidosis
- •Pregnant or lactating women
- •Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma
- •Any hospital admission for asthma within the last 6 months
- •Anti-IgE therapy at any time check/update interventions by explicitely writing the experimental drug dosage in the interventions description
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
Setipiprant - Dose 2
Experimental
500 mg b.i.d.
干预措施: Setipiprant (Drug)
Setipiprant - Dose 1
Experimental
100 mg b.i.d.
干预措施: Setipiprant (Drug)
Setipiprant - Dose 3
Experimental
1,000 mg b.i.d
干预措施: Setipiprant (Drug)
Matching Placebo
Placebo Comparator
Oral placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo
时间窗: Baseline to week 12
次要结局
- Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control(Baseline to 12 weeks)
研究者
研究点 (97)
Loading locations...
相似试验
已完成
2 期
Study of ACT-129968 in Adult Patients With Seasonal Allergic RhinitisSeasonal Allergic RhinitisNCT01241214Idorsia Pharmaceuticals Ltd.579
已完成
3 期
Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)AsthmaNCT00092144Organon and Co500
已完成
2 期
ACT-128800 in Patients With Moderate to Severe Chronic Plaque PsoriasisPsoriasisNCT01208090Actelion326
已完成
3 期
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe AsthmaAsthmaNCT00393952SkyePharma AG557
已完成
3 期
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With AsthmaAsthmaNCT00393991SkyePharma AG475