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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
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Chronic Rhinosinusitis
 Drug: Pulmozyme
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University of Jena:

Enrollment: 5
Study Start Date: December 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265434

Locations
Germany
Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07740
Sponsors and Collaborators
University of Jena
Investigators
Study Chair: Jochen G. Mainz, M.D. University of Jena
  More Information

No publications provided

Responsible Party: Dr. Jochen Mainz, University of Jena, Children`s hospital
ClinicalTrials.gov Identifier: NCT00265434     History of Changes
Other Study ID Numbers: pilot-pulmozyme-nasal-cf
Study First Received: December 13, 2005
Last Updated: October 10, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Sinusitis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013