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

University of Jena

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis; Cystic Fibrosis

Treatments: Drug: Pulmozyme

Study type: Interventional

Funder types: Other

Identifiers

NCT00265434

pilot-pulmozyme-nasal-cf

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Dornase alfa

Active Comparator group

Description:

DBPC-cross over trial

Treatment:

Drug: Pulmozyme

isotonic saline

Placebo Comparator group

Treatment:

Drug: Pulmozyme