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 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 a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Condition	Intervention	Phase
Cystic Fibrosis Rhinosinusitis	Drug: Dornase alfa (Pulmozyme)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Dornase alfa

U.S. FDA Resources

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) [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (secondary nasal parameters, general quality of live parameters and total SNOT 20 adapt. CF score) [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]
Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients) [ Time Frame: day 1, 29, 57, 85 ] [ Designated as safety issue: No ]
Changes in the nasal lavage fluid and in the serological markers of inflammation [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]
Changes in rhinoscopic findings [ Time Frame: day 1, 29, 57 and 85 ] [ Designated as safety issue: No ]
Changes in rhinomanometric findings [ Time Frame: day 1, 29, 27 and 85 ] [ Designated as safety issue: No ]
Incidence of rhinosinusitic and pulmonary exacerbations during therapy [ Time Frame: day 1 - 85 ] [ Designated as safety issue: No ]
Need for decongestants or nasal lavage during treatment [ Time Frame: day 1 - 85 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	September 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

1 x 2,5 mg per day, inhalation use, for 28 days

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

Locations

Germany
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany, 72076
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07740

Sponsors and Collaborators

University of Jena

Investigators

Study Chair:

Jochen Mainz, M.D.

University of Jena

More Information

No publications provided

Responsible Party:	Dr. Jochen Mainz, University of Jena, Children`s hospital
ClinicalTrials.gov Identifier:	NCT00534079 History of Changes
Other Study ID Numbers:	pulmozyme-nasal-cf
Study First Received:	September 21, 2007
Last Updated:	November 25, 2009
Health Authority:	Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by University of Jena:

Cystic Fibrosis and chronic rhinosinusitis

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Sinusitis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases

Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013