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

University of Jena5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cystic Fibrosis Chronic Rhinosinusitis

Interventions

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes