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

This study has been completed.
Sponsor:
Collaborators:
PD Dr. Joachim Riethmöller, Tübingen
PD Dr. Assen Koitschev, Tübingen
Dr. Gerlind Schneider
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena
ClinicalTrials.gov Identifier:
NCT00265434
First received: December 13, 2005
Last updated: December 3, 2014
Last verified: December 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Changes in sinonasal symptoms (SNOT-20 [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

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)
Arms Assigned Interventions
Active Comparator: Dornase alfa
DBPC-cross over trial
Drug: Pulmozyme
Placebo Comparator: isotonic saline Drug: Pulmozyme

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
PD Dr. Joachim Riethmöller, Tübingen
PD Dr. Assen Koitschev, Tübingen
Dr. Gerlind Schneider
Investigators
Study Chair: Jochen G. Mainz, M.D. University of Jena
  More Information

Publications:
Responsible Party: PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of Jena
ClinicalTrials.gov Identifier: NCT00265434     History of Changes
Other Study ID Numbers: pilot-pulmozyme-nasal-cf
Study First Received: December 13, 2005
Last Updated: December 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 04, 2015