NCT00416182

Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.

Detailed description

AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF) PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively. Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months. Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.

Conditions

• Sinusitis
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Pulmozyme (dornase alfa)	2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
DRUG	Placebo	2.5 mL of placebo delivered via Sinustar nebulizer device

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-12-27
• Last updated: 2014-11-14
• Results posted: 2014-11-14

Locations

1 site across 1 country: United States