CLINICAL TRIALS PROFILE FOR PULMOZYME

All Clinical Trials for PULMOZYME

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117208 ↗	Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis	Completed	Pharmaxis	Phase 2	2005-11-01	The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.
NCT00169962 ↗	Study of Pulmozyme to Treat Severe Asthma Episodes	Completed	Genentech, Inc.	Phase 2	2004-01-01	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.
NCT00169962 ↗	Study of Pulmozyme to Treat Severe Asthma Episodes	Completed	Northwell Health	Phase 2	2004-01-01	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.
NCT00179998 ↗	Effectiveness of Pulmozyme in Infants With Cystic Fibrosis	Completed	Genentech, Inc.	Phase 2	2005-01-01	This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age.
NCT00179998 ↗	Effectiveness of Pulmozyme in Infants With Cystic Fibrosis	Completed	Nationwide Children's Hospital	Phase 2	2005-01-01	This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age.

Clinical Trial Conditions for PULMOZYME

Condition Name

Condition Name for PULMOZYME
Intervention	Trials
Cystic Fibrosis	12
Ischemic Stroke	3
Sinusitis	2
COVID-19	2

Condition MeSH

Condition MeSH for PULMOZYME
Intervention	Trials
Fibrosis	13
Cystic Fibrosis	13
COVID-19	5
Infections	4

Clinical Trial Locations for PULMOZYME

Trials by Country

Trials by Country for PULMOZYME
Location	Trials
United States	69
Germany	4
Australia	2
Canada	2
Belgium	1

Trials by US State

Trials by US State for PULMOZYME
Location	Trials
Illinois	5
New York	5
North Carolina	4
Colorado	4
Texas	3

Clinical Trial Progress for PULMOZYME

Clinical Trial Phase

Clinical Trial Phase for PULMOZYME
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	4
Phase 2	12

Clinical Trial Status

Clinical Trial Status for PULMOZYME
Clinical Trial Phase	Trials
Completed	14
Not yet recruiting	5
Terminated	5

Clinical Trial Sponsors for PULMOZYME

Sponsor Name

Sponsor Name for PULMOZYME
Sponsor	Trials
Genentech, Inc.	12
McGill University Health Centre/Research Institute of the McGill University Health Centre	2
National University of Malaysia	2

Sponsor Type

Sponsor Type for PULMOZYME
Sponsor	Trials
Other	67
Industry	16
NIH	1