NCT00416182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 14, 2014

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

5.5 years

First QC Date

December 26, 2006

Results QC Date

October 2, 2012

Last Update Submit

November 12, 2014

Conditions

SinusitisCystic Fibrosis

Keywords

Cystic fibrosischronic sinusitismucolytic

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Chronic Sinusitis Survey Score

    baseline and 1 year

  • Pulmonary Function

    baseline and 1 year

Study Arms (2)

Pulmozyme

EXPERIMENTAL

2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily

Drug: Pulmozyme (dornase alfa)

placebo

PLACEBO COMPARATOR

2.5 mg/2mL placebo administered intranasally once daily

Drug: Placebo

Interventions

Pulmozyme (dornase alfa)DRUG

2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device

Also known as: Pulmozyme, dornase alfa, human recombinant DNase 1
Pulmozyme
PlaceboDRUG

2.5 mL of placebo delivered via Sinustar nebulizer device

Also known as: placebo comparator
placebo

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

  • 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.

    RESULT

  • 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.

    PMID: 33735508DERIVED

MeSH Terms

Conditions

SinusitisCystic Fibrosis

Interventions

dornase alfa

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPancreatic DiseasesDigestive System DiseasesLung DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Limitations and Caveats

recruitment for a long trial was difficult so enrollment was truncated.

Results Point of Contact

Title
Dr. Thomas Lahiri, Principal Investigator
Organization
Vermont Children's Hospital at Fletcher Allen Health Care
thomas.lahiri@vtmednet.org
802-847-8600

Study Officials

  • Thomas Lahiri, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

  • Sandra Diehl, MS

    University of Vermont Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

December 26, 2006

First Posted

December 27, 2006

Study Start

December 1, 2006

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 14, 2014

Results First Posted

November 14, 2014

Record last verified: 2014-11

Locations

US(1)