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

• Sponsor: University of Jena (Other)
• Overall Status: Completed
• CT.gov ID: NCT00265434
• Collaborator: PD Dr. Joachim Riethmöller, Tübingen (Other), PD Dr. Assen Koitschev, Tübingen (Other), Dr. Gerlind Schneider (Other)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Dec 1, 2005
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: May 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in sinonasal symptoms (SNOT-20 [2 yrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of Jena
• ClinicalTrials.gov Identifier: NCT00265434
• Other Study ID Numbers: pilot-pulmozyme-nasal-cf
• First Posted: Dec 14, 2005
• Last Update Posted: Dec 4, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Sinusitis; Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Dec 4, 2014