Study of Pulmozyme to Treat Severe Asthma Episodes

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00169962
First received: September 12, 2005
Last updated: December 21, 2007
Last verified: December 2007

September 12, 2005
December 21, 2007
January 2004
September 2006   (final data collection date for primary outcome measure)
FEV1
Same as current
Complete list of historical versions of study NCT00169962 on ClinicalTrials.gov Archive Site
Hospitalization
Same as current
Not Provided
Not Provided
 
Study of Pulmozyme to Treat Severe Asthma Episodes
Use of Aerosolized rhDNase (Pulmozyme®) in Emergency Department Adults With Refractory Acute Asthma: A Pilot Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: rhDNAse (pulmozyme)
Not Provided
Silverman RA, Foley F, Dalipi R, Kline M, Lesser M. The use of rhDNAse in severely ill, non-intubated adult asthmatics refractory to bronchodilators: a pilot study. Respir Med. 2012 Aug;106(8):1096-102. Epub 2012 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

other chronic lung illness pregnancy -

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00169962
03.05.086
Not Provided
Robert Silverman, MD, Emergency Medicine, LIJMC
North Shore Long Island Jewish Health System
Genentech
Principal Investigator: Robert A Silverman, MD LIJMC
North Shore Long Island Jewish Health System
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP