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

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ClinicalTrials.gov Identifier: NCT00265434
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : December 4, 2014
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

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Chronic Rhinosinusitis Drug: Pulmozyme Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Study Start Date : December 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Active Comparator: Dornase alfa
DBPC-cross over trial
Drug: Pulmozyme
Placebo Comparator: isotonic saline Drug: Pulmozyme



Primary Outcome Measures :
  1. Changes in sinonasal symptoms (SNOT-20 [ Time Frame: 2 yrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

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