Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT00265434
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2005-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568813', 'term': 'dornase alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2005-12-13', 'studyFirstSubmitQcDate': '2005-12-13', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in sinonasal symptoms (SNOT-20', 'timeFrame': '2 yrs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis', 'Chronic Rhinosinusitis']}, 'referencesModule': {'references': [{'pmid': '21030168', 'type': 'BACKGROUND', 'citation': 'Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmuller J, Koitschev A, Schneider G, Beck JF, Wiedemann B. Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial. Auris Nasus Larynx. 2011 Apr;38(2):220-7. doi: 10.1016/j.anl.2010.09.001. Epub 2010 Oct 27.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (most important):\n\n* Subject has a confirmed diagnosis of cystic fibrosis.\n* Subject has chronic or recurrent rhinosinusitic disorders.\n* Subject is 5 years or older.\n\nExclusion Criteria (most important):\n\n* Subject has a critical condition (FEV1\\<30% and SaO2\\<93%).\n* Subject had an ENT surgery within 6 months prior to study.'}, 'identificationModule': {'nctId': 'NCT00265434', 'briefTitle': 'Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis', 'orgStudyIdInfo': {'id': 'pilot-pulmozyme-nasal-cf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dornase alfa', 'description': 'DBPC-cross over trial', 'interventionNames': ['Drug: Pulmozyme']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'isotonic saline', 'interventionNames': ['Drug: Pulmozyme']}], 'interventions': [{'name': 'Pulmozyme', 'type': 'DRUG', 'armGroupLabels': ['Dornase alfa', 'isotonic saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07740', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich-Schiller-Universität', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Jochen G. Mainz, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Jena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'PD Dr. Joachim Riethmöller, Tübingen', 'class': 'UNKNOWN'}, {'name': 'PD Dr. Assen Koitschev, Tübingen', 'class': 'UNKNOWN'}, {'name': 'Dr. Gerlind Schneider', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of CF Center, Pediatric Pulmonology', 'investigatorFullName': 'PD Dr. Jochen G. Mainz', 'investigatorAffiliation': 'University of Jena'}}}}