Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

Phase 2

Completed

• Conditions: Sinusitis; Cystic Fibrosis
• Interventions: Drug: Pulmozyme (dornase alfa); Drug: Placebo

• Registration Number: NCT00416182
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-26
• Study First Submitted QC: 2006-12-26
• Study First Posted: 2006-12-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2012-10-02
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-12
• Last Update Submitted: 2014-11-12
• Results First Posted: 2014-11-14
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmozyme	Pulmozyme (dornase alfa)	2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily
placebo	Placebo	2.5 mg/2mL placebo administered intranasally once daily

Primary Outcome Measures

Name	Time	Method
Improvement in Appearance of Nasal Passages/Sinuses	baseline and 1 year	periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome).; independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)
Computed Tomography Evidence of Less Sinus Disease	baseline and 1 year	compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)

Secondary Outcome Measures

Name	Time	Method
Chronic Sinusitis Survey Score	baseline and 1 year	pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome.
Pulmonary Function	baseline and 1 year	prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome.

Trial Locations

Locations (1)

Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States