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NCT00169962 · ClinicalTrials.gov registry record · Phase 2
Study of Pulmozyme to Treat Severe Asthma Episodes
A Phase 2 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT00169962 is a Phase 2 study that has completed, run by Northwell Health. The registered enrollment target is 51 participants.
The verdict
NCT00169962, a Phase 2 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study 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.
Interventions
- DRUG rhDNAse (pulmozyme)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00169962
The ClinicalTrials.gov registry entry for NCT00169962 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rhDNAse (pulmozyme) is the first listed.
NCT00169962 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00169962 about?
NCT00169962 is a clinical study titled "Study of Pulmozyme to Treat Severe Asthma Episodes". 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 withi...
What is the current status of trial NCT00169962?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2004-01. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00169962?
The interventions under investigation include: rhDNAse (pulmozyme) (DRUG).
Who is sponsoring clinical trial NCT00169962?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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