临床试验/NCT00889837

NCT00889837已完成1 期

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

Alexza Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 53 人开始时间: 2009年6月最近更新: 2017年3月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Alexza Pharmaceuticals, Inc.
入组人数: 53
试验地点: 1
主要终点: Change in FEV1 from baseline by spirometry

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.

详细描述

To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.

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, Care Provider)

入排标准

年龄范围: 40 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.

排除标准

•History of asthma, or any other acute or chronic pulmonary disease.

研究组 & 干预措施

Inhaled Loxapine

Experimental

Staccato Loxapine, 10 mg doses x 2, 10 hours apart

干预措施: Inhaled Loxapine (Drug)

Inhaled Placebo

Placebo Comparator

Staccato Placebo,inhalations x 2, 10 hours apart

干预措施: Inhaled Placebo (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

Treatment emergent adverse events(Post-treatment time points)
Change in FVC from baseline by spirometry(at each post-treatment time point (15 min to 34 hr))

研究者

发起方

Alexza Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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