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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

December 13, 2005
December 3, 2014
December 2005
May 2006   (final data collection date for primary outcome measure)
Changes in sinonasal symptoms (SNOT-20 [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00265434 on ClinicalTrials.gov Archive Site
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Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Chronic Rhinosinusitis
Drug: Pulmozyme
  • Active Comparator: Dornase alfa
    DBPC-cross over trial
    Intervention: Drug: Pulmozyme
  • Placebo Comparator: isotonic saline
    Intervention: Drug: Pulmozyme
Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmüller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
5 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00265434
pilot-pulmozyme-nasal-cf
Yes
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PD Dr. Jochen G. Mainz, University of Jena
University of Jena
  • PD Dr. Joachim Riethmöller, Tübingen
  • PD Dr. Assen Koitschev, Tübingen
  • Dr. Gerlind Schneider
Study Chair: Jochen G. Mainz, M.D. University of Jena
University of Jena
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP