NCT00265434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

December 13, 2005

Last Update Submit

December 3, 2014

Conditions

Cystic FibrosisChronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • Changes in sinonasal symptoms (SNOT-20

    2 yrs

Study Arms (2)

Dornase alfa

ACTIVE COMPARATOR

DBPC-cross over trial

Drug: Pulmozyme

isotonic saline

PLACEBO COMPARATOR
Drug: Pulmozyme

Interventions

PulmozymeDRUG
Dornase alfaisotonic saline

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich-Schiller-Universität

Jena, Thuringia, 07740, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21030168BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

dornase alfa

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Jochen G. Mainz, M.D.

    University of Jena

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of CF Center, Pediatric Pulmonology

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

December 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

DE(1)