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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: rhDNAse (pulmozyme)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Use of Aerosolized rhDNase (Pulmozyme®) in Emergency Department Adults With Refractory Acute Asthma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • FEV1

Secondary Outcome Measures:
  • Hospitalization

Estimated Enrollment: 51
Study Start Date: January 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

other chronic lung illness pregnancy -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169962

Locations
United States, New York
LIJMC
Queens, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Genentech
Investigators
Principal Investigator: Robert A Silverman, MD LIJMC
  More Information

No publications provided by North Shore Long Island Jewish Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Silverman, MD, Emergency Medicine, LIJMC
ClinicalTrials.gov Identifier: NCT00169962     History of Changes
Other Study ID Numbers: 03.05.086
Study First Received: September 12, 2005
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:
acute disease

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014