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Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

NCT ID: NCT00416182

Last Updated: 2014-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Sinusitis Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pulmozyme

2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily

Group Type EXPERIMENTAL

Pulmozyme (dornase alfa)

Intervention Type DRUG

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

placebo

2.5 mg/2mL placebo administered intranasally once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2.5 mL of placebo delivered via Sinustar nebulizer device

Interventions

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Pulmozyme (dornase alfa)

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

Intervention Type DRUG

Placebo

2.5 mL of placebo delivered via Sinustar nebulizer device

Intervention Type DRUG

Other Intervention Names

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Pulmozyme, dornase alfa, human recombinant DNase 1 placebo comparator

Eligibility Criteria

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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)
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Thomas Lahiri

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Lahiri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Sandra Diehl, MS

Role: STUDY_DIRECTOR

University of Vermont Medical Center

Locations

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Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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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.

Reference Type 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.

Reference Type DERIVED
PMID: 33735508 (View on PubMed)

Other Identifiers

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Z3297S

Identifier Type: -

Identifier Source: org_study_id