Study of Pulmozyme to Treat Severe Asthma Episodes

NCT ID: NCT00169962

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2006-09-30

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 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

rhDNAse (pulmozyme)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

other chronic lung illness pregnancy -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Robert A Silverman

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert A Silverman, MD

Role: PRINCIPAL_INVESTIGATOR

LIJMC

Locations

LIJMC

Queens, New York, United States

Countries

United States

References

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. doi: 10.1016/j.rmed.2012.04.002. Epub 2012 May 12.

Reference Type: DERIVED

PMID: 22580235 (View on PubMed)

Other Identifiers

03.05.086

Identifier Type: -

Identifier Source: org_study_id