Trial | NCT00265434  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    5
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 Started
Dec 31
2005
Primary Completion
May 31
2006
Study Completion
May 31
2006
Last Update
Dec 04
2014
Estimate

Drug Pulmozyme

Dornase alfa Active Comparator

DBPC-cross over trial

isotonic saline Placebo Comparator

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.
No Results Posted