Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416182
• Other study ID #: Z3297S
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2006
• Last updated: November 12, 2014
• Start date: December 2006
• Est. completion date: June 2012

Study information

• Verified date: November 2014
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Sinusitis

Intervention

Drug:
• Pulmozyme (dornase alfa)
2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
• Placebo
2.5 mL of placebo delivered via Sinustar nebulizer device

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lahiri T, Herrington H, Diehl S, Landrigan G. The effect of intranasal dornase alfa on chronic sinusitis in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol S35:354, 2012.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computed Tomography Evidence of Less Sinus Disease	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)	baseline and 1 year	No
Primary	Improvement in Appearance of Nasal Passages/Sinuses	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)	baseline and 1 year	No
Secondary	Chronic Sinusitis Survey Score	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.	baseline and 1 year	No
Secondary	Pulmonary Function	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.	baseline and 1 year	No