NCT01095276

Brief Summary

The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

July 28, 2009

Last Update Submit

March 29, 2010

Conditions

AtelectasisVentilation, Mechanical

Keywords

Mechanical VentilationExtubationdornase alphaoxygenationchest x ray

Outcome Measures

Primary Outcomes (1)

  • Total Chest X Ray Score

    Days 0-30

Secondary Outcomes (3)

  • Oxygenation (Pa02/FI02)

    Days 0-30

  • Static Lung Compliance

    Days 0-30

  • Time to Extubation

    Days 0-30

Study Arms (2)

Nebulized saline

PLACEBO COMPARATOR

patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)

Drug: Saline

dornase alpha

ACTIVE COMPARATOR

patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization

Drug: Pulmozyme (nebulized dornase alpha)

Interventions

Pulmozyme (nebulized dornase alpha)DRUG

nebulized dornase alpha: 2.5 mg by in-line nebulizer BID

Also known as: Pulmozyme, DNase
dornase alpha
SalineDRUG

Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).

Nebulized saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current ventilator use
  • onset of lobar or whole lung collapse over the previous 12 hours
  • age greater than 18

You may not qualify if:

  • quadriplegia or debilitating neuromuscular condition
  • chronic ventilator dependence
  • pneumothorax
  • frank hemoptysis
  • elevated intracranial pressure
  • intracranial bleed
  • pregnancy or active nursing
  • concurrent use of other investigational drugs
  • history of allergy to Pulmozyme®, Chinese Hamster Ovary-derived biologics, or any of the components of the active or placebo formulations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07183, United States

Location

MeSH Terms

Conditions

Pulmonary AtelectasisRespiratory Aspiration

Interventions

dornase alfaDeoxyribonucleasesSodium Chloride

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EsterasesHydrolasesEnzymesEnzymes and CoenzymesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jessica N Zitter, MD, MPH

    UMDNJ, Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

March 30, 2010

Study Start

November 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

US(1)