NCT00671723

Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients

Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis. We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.

Conditions

• Atelectasis

Interventions

Type	Name	Description
DRUG	Normal saline:	Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
DRUG	Hypertonic Saline	Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
DRUG	Dornase alpha	2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-05-05
• Last updated: 2017-07-02
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States