Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients

Atelectasis Clinical Trial

Official title:

Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095276
• Other study ID #: 0120030304
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: March 29, 2010
• Start date: November 2005
• Est. completion date: January 2006

Study information

• Verified date: March 2010
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis
• Ventilation, Mechanical

Intervention

Drug:
• Pulmozyme (nebulized dornase alpha)
nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
• Saline
Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).

Locations

Country	Name	City	State
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Chest X Ray Score		Days 0-30	No
Secondary	Oxygenation (Pa02/FI02)		Days 0-30	No
Secondary	Static Lung Compliance		Days 0-30	No
Secondary	Time to Extubation		Days 0-30	No