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Completed

NCT Number: NCT00416182

Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

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.

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Key information

Conditions

Sinusitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Nose Diseases Otorhinolaryngologic Diseases Pancreatic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pulmozyme (dornase alfa)

Drug

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

Other names: Pulmozyme, dornase alfa, human recombinant DNase 1

Placebo

Drug

2.5 mL of placebo delivered via Sinustar nebulizer device

Other names: placebo comparator

Primary outcomes

  1. Computed Tomography Evidence of Less Sinus Disease

    Time frame: 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)

  2. Improvement in Appearance of Nasal Passages/Sinuses

    Time frame: 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)

Secondary outcomes

  1. Chronic Sinusitis Survey Score

    Time frame: 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.

  2. Pulmonary Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Dec 27, 2006
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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