Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 5:55 PM
Study NCT ID:
NCT00890734
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2009-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C559986', 'term': 'CYT003-QbG10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Markers for inflammation and asthma', 'timeFrame': '1-3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Bronchial Asthma']}, 'referencesModule': {'references': [{'pmid': '23384679', 'type': 'DERIVED', 'citation': 'Beeh KM, Kanniess F, Wagner F, Schilder C, Naudts I, Hammann-Haenni A, Willers J, Stocker H, Mueller P, Bachmann MF, Renner WA. The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 2013 Mar;131(3):866-74. doi: 10.1016/j.jaci.2012.12.1561. Epub 2013 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids\n* Further criteria as defined in the study protocol\n\nExclusion Criteria:\n\n* Use of oral corticosteroids within past 3 months\n* Hospitalization for asthma exacerbation within past 6 months\n* Uncontrolled asthma\n* Contraindication to any study test or procedure\n* Further criteria as defined in the study protocol'}, 'identificationModule': {'nctId': 'NCT00890734', 'briefTitle': 'CYT003-QbG10 for Treatment of Allergic Asthma Bronchial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytos Biotechnology AG'}, 'officialTitle': 'A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial', 'orgStudyIdInfo': {'id': 'CYT003-QbG10 11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: CYT003-QbG10']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CYT003-QbG10', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach', 'country': 'Germany', 'facility': 'Cytos Investigator Sites'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytos Biotechnology AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}