Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01095276
First received: July 28, 2009
Last updated: March 29, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Atelectasis
Ventilation, Mechanical
Drug: Pulmozyme (nebulized dornase alpha)
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Total Chest X Ray Score [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxygenation (Pa02/FI02) [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
  • Static Lung Compliance [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
  • Time to Extubation [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Nebulized saline
patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
Drug: Saline
Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).
Active Comparator: dornase alpha
patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization
Drug: Pulmozyme (nebulized dornase alpha)
nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
Other Names:
  • Pulmozyme
  • DNase

Detailed Description:

Background: Lobar or segmental collapse of the lung in mechanically ventilated patients is a relatively common occurrence in the Intensive Care Unit. Available treatments are either labor or time intensive and not highly effective.

Methods: We conducted a randomized, placebo-controlled, double-blind pilot study to determine whether nebulized recombinant human dornase alpha (Pulmozyme, Genentech) improves radiologic and clinical outcomes in ventilated patients with lobar atelectasis. Outcomes of interest were chest radiograph score, oxygenation, lung compliance, and rate of extubation over the first 5 days. The groups consisted of 14 intervention patients and 16 control patients. They were similar with respect to basic demographics, age, gender, and use of therapeutic modalities relating to lung function. Baseline average chest x-ray scores, Pa02/FI02 ratios, and static compliance were not significantly different. Analysis was limited to the first 5 days.

Results: There was a significant improvement in oxygenation for the intervention group at day 5 (p=0.03). There were no significant differences in chest radiograph score, compliance, or rate of extubation. Two patients died in the intervention group, whereas none died in the control group (NS).

Conclusions: These pilot data suggest that inhaled dornase alpha appears to be safe and is associated with improved oxygenation 5 days after initiation of therapy in mechanically ventilated patients compared to placebo. Larger studies are needed to confirm these findings and determine if this intervention decreases ICU morbidity and mortality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01095276

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07183
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Jessica N Zitter, MD, MPH UMDNJ, Department of Medicine
  More Information

No publications provided

Responsible Party: Jessica Nutik Zitter, MD, MPH, University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT01095276     History of Changes
Other Study ID Numbers: 0120030304
Study First Received: July 28, 2009
Last Updated: March 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
Mechanical Ventilation
Extubation
dornase alpha
oxygenation
chest x ray

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014