NCT00890175已完成1 期
Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in FEV1 from baseline by spirometry
研究概览
简要总结
The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value.
排除标准
- •History of COPD, or any other acute or chronic pulmonary disease
研究组 & 干预措施
Inhaled loxapine @ 0 & 10 h
Experimental
Inhalation of 10 mg of loxapine at 0 and 10 hours
干预措施: Inhaled loxapine @ 0 & 10 h (Drug)
Inhaled placebo @ 2 & 10 hours
Placebo Comparator
Inhalation of 0 mg of loxapine (placebo) at 0 and 10 hours
干预措施: Inhaled placebo @ 2 & 10 hours (Drug)
结局指标
主要结局
Change in FEV1 from baseline by spirometry
时间窗: at each post-treatment time point (15 min to 34 hr)
次要结局
- Change in FVC from baseline by spirometry(at each post-treatment time point (15 min to 34 hr))
- Treatment emergent adverse events(Post-treatment time points)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Staccato Loxapine Pulmonary Safety in Patients With COPDChronic Obstructive Pulmonary DiseaseNCT00889837Alexza Pharmaceuticals, Inc.53
已完成
1 期
Staccato Loxapine Pulmonary Safety in Healthy VolunteersHealthyNCT00789360Alexza Pharmaceuticals, Inc.30
已完成
1 期
Staccato Loxapine PK in Smokers and NonsmokersSmoking, CigaretteNCT00873769Alexza Pharmaceuticals, Inc.35
已完成
2 期
Staccato Loxapine in Agitation (Proof of Concept)SchizophreniaNCT00369577Alexza Pharmaceuticals, Inc.129
已完成
2 期
Staccato Loxapine in Migraine (in Clinic)MigraineNCT00489476Alexza Pharmaceuticals, Inc.168