Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

December 3, 2014 updated by: PD Dr. Jochen G. Mainz, University of Jena

Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of Chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections.

The prospective placebo controlled cross-over study aims at the evaluation of the efficacy of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thüringen
      • Jena, Thüringen, Germany, 07740
        • Friedrich-Schiller-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (most important):

  • Subject has a confirmed diagnosis of cystic fibrosis.
  • Subject has chronic or recurrent rhinosinusitic disorders.
  • Subject is 5 years or older.

Exclusion Criteria (most important):

  • Subject has a critical condition (FEV1<30% and SaO2<93%).
  • Subject had an ENT surgery within 6 months prior to study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dornase alfa
DBPC-cross over trial
Drug: Pulmozyme
Placebo Comparator: isotonic saline
Drug: Pulmozyme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in sinonasal symptoms (SNOT-20
Time Frame: 2 yrs
2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

PD Dr. Joachim Riethmöller, Tübingen
PD Dr. Assen Koitschev, Tübingen
Dr. Gerlind Schneider

Investigators

  • Study Chair: Jochen G. Mainz, M.D., University of Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

December 13, 2005

First Submitted That Met QC Criteria

December 13, 2005

First Posted (Estimate)

December 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pilot-pulmozyme-nasal-cf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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