Conditions: Sinusitis Cystic Fibrosis
Keywords: Cystic fibrosis chronic sinusitis mucolytic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily arm 2: 2.5 mg/2mL placebo administered intranasally once daily

Interventions: intervention 1: Pulmozyme (dornase alfa) intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device intervention 2: 2.5 mL of placebo delivered via Sinustar nebulizer device

Protocol document: