Back to resultsNasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Primary Purpose
Cystic Fibrosis, Chronic Rhinosinusitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pulmozyme
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
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.
Sites / Locations
- Friedrich-Schiller-Universität
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dornase alfa
isotonic saline
Arm Description
DBPC-cross over trial
Outcomes
Primary Outcome Measures
Changes in sinonasal symptoms (SNOT-20
Secondary Outcome Measures
Full Information
NCT ID
NCT00265434
First Posted
December 13, 2005
Last Updated
December 3, 2014
Sponsor
University of Jena
Collaborators
PD Dr. Joachim Riethmöller, Tübingen, PD Dr. Assen Koitschev, Tübingen, Dr. Gerlind Schneider
1. Study Identification
Unique Protocol Identification Number
NCT00265434
Brief Title
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Official Title
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
PD Dr. Joachim Riethmöller, Tübingen, PD Dr. Assen Koitschev, Tübingen, Dr. Gerlind Schneider
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Chronic Rhinosinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dornase alfa
Arm Type
Active Comparator
Arm Description
DBPC-cross over trial
Arm Title
isotonic saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pulmozyme
Primary Outcome Measure Information:
Title
Changes in sinonasal symptoms (SNOT-20
Time Frame
2 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen G. Mainz, M.D.
Organizational Affiliation
University of Jena
Official's Role
Study Chair
Facility Information:
Facility Name
Friedrich-Schiller-Universität
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07740
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21030168
Citation
Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmuller J, Koitschev A, Schneider G, Beck JF, Wiedemann B. Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial. Auris Nasus Larynx. 2011 Apr;38(2):220-7. doi: 10.1016/j.anl.2010.09.001. Epub 2010 Oct 27.
Results Reference
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Learn more about this trial
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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