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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265434
• Other study ID #: pilot-pulmozyme-nasal-cf
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2005
• Last updated: December 3, 2014
• Start date: December 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2014
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Cystic Fibrosis
• Fibrosis
• Sinusitis

Intervention

Drug:
• Pulmozyme

Locations

Country	Name	City	State
Germany	Friedrich-Schiller-Universität	Jena	Thüringen

Sponsors (4)

Lead Sponsor	Collaborator
University of Jena	Dr. Gerlind Schneider, PD Dr. Assen Koitschev, Tübingen, PD Dr. Joachim Riethmöller, Tübingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sinonasal symptoms (SNOT-20		2 yrs	Yes