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临床试验/NCT00169962
NCT00169962已完成2 期

Use of Aerosolized rhDNase (Pulmozyme®) in Emergency Department Adults With Refractory Acute Asthma: A Pilot Study

Northwell Health2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2004年1月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
51
试验地点
2
主要终点
FEV1

研究概览

简要总结

Even with current standard ED treatments 20-25% of patients presenting to the ED with an acute asthma episode will still require hospitalization. For patients unresponsive to beta-agonists the admit rates will be higher. Of those well enough to be discharged from the ED nearly 30% will relapse within one month. More than 5,000 patients with asthma still die each year in the USA. For patients who do not respond to beta-agonists, there are relatively few treatment options for rapid improvement of symptoms and pulmonary function. Presumably, mucous secretion and plugging play an important role in the pathogenesis of severe asthma unresponsive to beta-agonists. The use of agents to promote clearance of intra-luminal secretions and mucous plugs may represent an important advance in the management of acutely ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting and to prevent relapse after discharge from the ED.

OBJECTIVES

2.1 Study Hypothesis: rhDNAse can be safely used in patients presenting to the Emergency Department with acute moderate-severe asthma who do not have adequate responses to beta-agonists

Project Specific Aim: This is a pilot study to determine the safety of three different doses of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ED with acute asthma. In addition to safety trends for improvement in pulmonary function and clinical outcomes will be monitored and data analyzed. Based on the safety profile and observable responses to treatment, this information may be used to develop larger trials to determine the efficacy and dosing strategy for treating acutely ill asthmatics with rhDNAse.

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • acute asthma FEV1<60% post-standard care age 18-55 years -

排除标准

  • other chronic lung illness pregnancy -

结局指标

主要结局

FEV1

次要结局

  • Hospitalization

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert A Silverman

Physician

Northwell Health

研究点 (2)

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