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Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01095276
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
Information provided by:
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Atelectasis Ventilation, Mechanical Drug: Pulmozyme (nebulized dornase alpha) Drug: Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients
Study Start Date : November 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Total Chest X Ray Score [ Time Frame: Days 0-30 ]

Secondary Outcome Measures :
  1. Oxygenation (Pa02/FI02) [ Time Frame: Days 0-30 ]
  2. Static Lung Compliance [ Time Frame: Days 0-30 ]
  3. Time to Extubation [ Time Frame: Days 0-30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01095276

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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
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Principal Investigator: Jessica N Zitter, MD, MPH UMDNJ, Department of Medicine
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Responsible Party: Jessica Nutik Zitter, MD, MPH, University of Medicine and Dentistry of New Jersey Identifier: NCT01095276    
Other Study ID Numbers: 0120030304
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010
Keywords provided by Rutgers, The State University of New Jersey:
Mechanical Ventilation
dornase alpha
chest x ray
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases