Dornase alfa as postoperative therapy in cystic fibrosis sinonasal disease.
OBJECTIVE
To determine the benefit of nasally inhaled dornase alfa in patients with cystic fibrosis and nasal symptoms.


METHODS
Double-blind placebo-controlled trial.


METHODS
Cystic Fibrosis Regional Center of Campania at the University of Naples "Federico II."


METHODS
A total of 24 patients with cystic fibrosis and chronic sinusitis.


METHODS
Patients underwent sinonasal surgery during a 3-year period and received once-daily doses of either dornase alfa (2.5 mg) or hypotonic saline solution (5 mL) beginning 1 month after surgery and for a 12-month period.


METHODS
Primary outcomes were nasal-related symptoms and nasal endoscopic appearance; secondary outcomes were forced expiratory volume in 1 second, nasal computed tomography findings, and saccharine clearance test results. Patients were evaluated before and after treatment.


RESULTS
After surgery, all outcomes were significantly improved for each treatment at 1 month (P<.05); primary outcomes were improved at 24 and 48 weeks in the group receiving dornase alfa (P<.05), and at 12 weeks in the group receiving placebo. Secondary outcomes were better in the dornase alfa group (P<.01) than in the placebo group at 12 months except for the saccharine clearance test results. In particular, median relative difference in forced expiratory volume in 1 second between dornase alfa and placebo was significantly improved in the dornase alfa group (P<.01).


CONCLUSIONS
Nasally inhaled dornase alfa can be effective in patients with cystic fibrosis and sinonasal disease who do not respond to conventional therapy after surgical treatment. Further studies should be carried out to determine the long-term effect on sinus disease, recurrence of polyps, and quality of life.
Cimmino
Mariano
M
Department of Otorhinolaryngology, University of Naples Federico II, Italy.
Nardone
Massimiliano
M
Cavaliere
Matteo
M
Plantulli
Angela
A
Sepe
Angela
A
Esposito
Valeria
V
Mazzarella
Giuseppina
G
Raia
Valeria
V
D000281:Administration, Intranasal; D000293:Adolescent; D002648:Child; D003550:Cystic Fibrosis / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D003850:Deoxyribonuclease I / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005100:Expectorants / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D011182:Postoperative Care; D011446:Prospective Studies; D011994:Recombinant Proteins; D012852:Sinusitis / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery*; D016896:Treatment Outcome
D005100:Expectorants; D011994:Recombinant Proteins; C085693:DNASE1 protein, human; D003850:Deoxyribonuclease I