Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169962
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2005-09-12
Brief Title:
Study of Pulmozyme to Treat Severe Asthma Episodes
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Use of Aerosolized rhDNase Pulmozyme in Emergency Department Adults With Refractory Acute Asthma A Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 5000 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
21 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 25mg 50mg and 75mg 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
OBJECTIVES
21 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 25mg 50mg and 75mg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None