Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients... | NCT00265434

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

NCT00265434

Sponsor

University of Jena

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

5Actual

Phase

Phase 3

Conditions

Cystic Fibrosis
Chronic Rhinosinusitis

Interventions

Pulmozyme

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Dec 13, 2005

First Submission Date that Met QC Criteria

Dec 13, 2005

First Posted Date

Dec 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of JenaPrincipal Investigator

Lead Sponsor

University of JenaOTHER

Collaborators

Name	Class
PD Dr. Joachim Riethmöller, Tübingen	UNKNOWN
PD Dr. Assen Koitschev, Tübingen	UNKNOWN
Dr. Gerlind Schneider	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dornase alfa	Active Comparator	DBPC-cross over trial	Drug: Pulmozyme
isotonic saline	Placebo Comparator		Drug: Pulmozyme

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmozyme	Drug		Dornase alfa isotonic saline

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen G. Mainz, M.D.	University of Jena	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Friedrich-Schiller-Universität		Jena	Thuringia	07740	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21030168	Background	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.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases