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.

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.