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Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

Primary Purpose

Sinusitis, Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pulmozyme (dornase alfa)
Placebo
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring Cystic fibrosis, chronic sinusitis, mucolytic

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Fletcher Allen Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pulmozyme

placebo

Arm Description

2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily

2.5 mg/2mL placebo administered intranasally once daily

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 26, 2006
Last Updated
November 12, 2014
Sponsor
University of Vermont
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00416182
Brief Title
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Official Title
The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Cystic Fibrosis
Keywords
Cystic fibrosis, chronic sinusitis, mucolytic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmozyme
Arm Type
Experimental
Arm Description
2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2.5 mg/2mL placebo administered intranasally once daily
Intervention Type
Drug
Intervention Name(s)
Pulmozyme (dornase alfa)
Other Intervention Name(s)
Pulmozyme, dornase alfa, human recombinant DNase 1
Intervention Description
2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo comparator
Intervention Description
2.5 mL of placebo delivered via Sinustar nebulizer device
Primary Outcome Measure Information:
Title
Computed Tomography Evidence of Less Sinus Disease
Description
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)
Time Frame
baseline and 1 year
Title
Improvement in Appearance of Nasal Passages/Sinuses
Description
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)
Time Frame
baseline and 1 year
Secondary Outcome Measure Information:
Title
Chronic Sinusitis Survey Score
Description
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.
Time Frame
baseline and 1 year
Title
Pulmonary Function
Description
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.
Time Frame
baseline and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lahiri, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Diehl, MS
Organizational Affiliation
University of Vermont Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
33735508
Citation
Yang C, Montgomery M. Dornase alfa for cystic fibrosis. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD001127. doi: 10.1002/14651858.CD001127.pub5.
Results Reference
derived

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Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

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