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

This study has been completed.

Sponsor:

Information provided by:

University of Jena

ClinicalTrials.gov Identifier:

NCT00265434

First received: December 13, 2005

Last updated: October 10, 2008

Last verified: September 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2005

Last Updated Date

October 10, 2008

Start Date ^ICMJE

December 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00265434 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Condition ^ICMJE

Cystic Fibrosis
Chronic Rhinosinusitis

Intervention ^ICMJE

Drug: Pulmozyme

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00265434

Other Study ID Numbers ^ICMJE

pilot-pulmozyme-nasal-cf

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Jochen Mainz, University of Jena, Children`s hospital

Study Sponsor ^ICMJE

University of Jena

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jochen G. Mainz, M.D.

University of Jena

Information Provided By

University of Jena

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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