Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - Full Text View

Purpose

Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life ennormously 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 a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Condition	Intervention	Phase
Cystic Fibrosis Rhinosinusitis	Drug: Dornase alfa (Pulmozyme)	Phase III

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

ChemIDplus related topics:

Salicylsalicylic acid Sodium salicylate Dornase alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment

Official Title:	Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-Controlled Cross-Over, Bicenter, Prospective Clinical Study

Further study details as provided by University of Jena:

Primary Outcome Measures:

Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches)

Study Start Date:

September 2007

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a confirmed diagnosis of cystic fibrosis based on: 3 positive sweat chloride tests and/or genetic characterisation
Subject is 5 years of age or older
Subject has chronic or recurrent rhinosinusitic disorders
Subject is able to comply with the procedures scheduled in the protocol
Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (e.g. implants, combined oral contraceptives, injectables, some IUDs, sexual abstinence or vasectomised partner)

Exclusion Criteria:

Subject has a critical condition defined as: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution
Subject had an ENT surgery within 6 months prior to study
Subject shows signs of nasal bleeding
Subject has an ear drum perforation
Subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy
Subject has a new therapy with nasal topic steroids during treatment interval
Subject has a new systemic steroid therapy
Subject is unlikely to comply with the procedures scheduled in the protocol
Subject has a known allergic reaction to the medication
Subject is pregnant or breastfeeding
Patient participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534079

Contacts


Contact: Isabella Schiller	+49-3641-938428	isabella.schiller@med.uni-jena.de

Locations


Germany, Baden-Würtemberg
	Universitäts-Kinderklinik	Not yet recruiting
	Tübingen, Baden-Würtemberg, Germany, 72076
	Contact: Joachim Riethmüller, M.D. +49-7071-2981391 joachim.riethmüller@med.uni-tuebingen.de
	Principal Investigator: Joachim Riethmüller, M.D.

Germany, Thüringen
	Mukoviszidosezentrum der Friedrich-Schiller-Universität	Recruiting
	Jena, Thüringen, Germany, 07740
	Contact: Jochen Mainz, M.D. +49-3641-938425 Jochen.Mainz@med.uni-jena.de
	Principal Investigator: Jochen Mainz, M.D.

Sponsors and Collaborators

University of Jena

Investigators


Study Chair:	Jochen Mainz, M.D.	University of Jena

More Information

Study ID Numbers:	pulmozyme-nasal-cf
First Received:	September 21, 2007
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00534079
Health Authority:	Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by University of Jena:

Cystic Fibrosis and chronic rhinosinusitis

Study placed in the following topic categories:

Digestive System Diseases

Genetic Diseases, Inborn

Respiratory Tract Diseases

Cystic Fibrosis

Fibrosis

Lung Diseases

Salicylsalicylic acid

Sodium Salicylate

Infant, Newborn, Diseases

Pancreatic Diseases

Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00534079