Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

University of Vermont

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis; Sinusitis

Treatments: Drug: Placebo; Drug: Pulmozyme (dornase alfa)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00416182

Z3297S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical and laboratory diagnosis of cystic fibrosis
• Age greater than or equal to 5 years
• Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
• Sinus surgery within one week of enrollment

Exclusion criteria

• Pregnancy
• Intolerance of orally inhaled Pulmozyme (dornase alfa)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Pulmozyme

Experimental group

Description:

2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily

Treatment:

Drug: Pulmozyme (dornase alfa)

placebo

Placebo Comparator group

Description:

2.5 mg/2mL placebo administered intranasally once daily

Treatment:

Drug: Placebo