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.

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Key information

Conditions

Cystic Fibrosis Chronic Rhinosinusitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Friedrich-Schiller-Universität

Jena, Thuringia, 07740, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmozyme

Drug

Primary outcomes

Changes in sinonasal symptoms (SNOT-20

Time frame: 2 yrs

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

Dr. Gerlind Schneider
PD Dr. Assen Koitschev, Tübingen
PD Dr. Joachim Riethmöller, Tübingen

Registry information

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Dec 14, 2005
Registry last updated: Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed