Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-02 @ 2:54 AM
Study NCT ID:
NCT00770003
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609563', 'term': 'AZD8848'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2008-10-08', 'studyFirstSubmitQcDate': '2008-10-08', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments', 'timeFrame': 'During the study'}, {'measure': 'Nasal symptoms, peak nasal inspiratory flow', 'timeFrame': 'During the study'}], 'secondaryOutcomes': [{'measure': 'Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow', 'timeFrame': 'During the study'}, {'measure': 'Blood biomarkers and nasal lavage biomarkers', 'timeFrame': 'During the study'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'During the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patients', 'allergic rhinitis', 'tolerability', 'safety', 'nasal symptoms'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '26342289', 'type': 'DERIVED', 'citation': 'Greiff L, Ahlstrom-Emanuelsson C, Alenas M, Almqvist G, Andersson M, Cervin A, Dolata J, Lindgren S, Martensson A, Young B, Widegren H. Biological effects and clinical efficacy of a topical Toll-like receptor 7 agonist in seasonal allergic rhinitis: a parallel group controlled phase IIa study. Inflamm Res. 2015 Nov;64(11):903-15. doi: 10.1007/s00011-015-0873-2. Epub 2015 Sep 5.'}, {'pmid': '22726593', 'type': 'DERIVED', 'citation': 'Greiff L, Cervin A, Ahlstrom-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Hogestatt E, Kallen A, Norlen P, Sjolin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13(1):53. doi: 10.1186/1465-9921-13-53.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1657&filename=D0540C00003_Study_Synopsis.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)\n* Patients with need of treatment for their nasal symptoms during the pollen season\n\nExclusion Criteria:\n\n* Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis\n* Symptomatic perennial allergic or non-allergic rhinitis\n* A history of asthma'}, 'identificationModule': {'nctId': 'NCT00770003', 'briefTitle': 'Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Placebo Controlled, Randomized, Parallel Group Study to Investigate the Tolerability, Safety, Pharmacodynamics and Pharmacokinetics of Repeated Weekly Doses of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients', 'orgStudyIdInfo': {'id': 'D0540C00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD8848']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD8848', 'type': 'DRUG', 'description': 'nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'nasal spray solution. Once weekly intranasal administrations for one month.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Lennart Greiff, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University Hospital'}, {'name': 'Leif T Eriksson, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}