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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265434

Enrollment

Registered

2005-12-14

Start date

2005-12-31

Completion date

2006-05-31

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis, Cystic Fibrosis

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.

Interventions

DRUGPulmozyme

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes in sinonasal symptoms (SNOT-20	2 yrs

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026