Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 6:37 AM
Study NCT ID:
NCT01992835
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resolution of Allergic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-11-22', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical nasal score and measurement of mediators in biological fluids', 'timeFrame': 'Measurement of mediators in biological fluids during 72 h after nasal allergen challenge'}, {'measure': 'Clinical nasal score and measurement of mediators in biological fluids.', 'timeFrame': 'Measurement and indentification of specific lipid mediators during nasal allergen challenge'}]}, 'conditionsModule': {'conditions': ['Grass Pollen Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '28073613', 'type': 'DERIVED', 'citation': 'Qi S, Barnig C, Charles AL, Poirot A, Meyer A, Clere-Jehl R, de Blay F, Geny B. Effect of nasal allergen challenge in allergic rhinitis on mitochondrial function of peripheral blood mononuclear cells. Ann Allergy Asthma Immunol. 2017 Mar;118(3):367-369. doi: 10.1016/j.anai.2016.11.026. Epub 2017 Jan 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'After an allergen challenge, the allergic inflammatory response disappears spontaneously. The initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. Recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. Only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. Therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility criteria:\n\nInclusion Criteria\n\n* Allergic rhinitis during the grass pollen season with or without asthma, with at least one of the following symptoms: nasal congestion, itching, rhinorrhea, sneezing\n* Grass pollen sensitization determined by a positive skin prick test and / or presence of specific IgEs to a grass pollen allergen extract\n\nExclusion Criteria:\n\n* Smoker\n* Specific immunotherapy with grass allergens or other respiratory allergen for inclusion.\n* Current exhibition to another clinically relevant respiratory allergen'}, 'identificationModule': {'nctId': 'NCT01992835', 'briefTitle': 'Resolution of Allergic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Resolution of Allergic Inflammation: Identification and Kinetics of Specific Lipid Mediators During Nasal Allergen Challenge', 'orgStudyIdInfo': {'id': '5507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'measurement of mediators in biological fluids', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Grass pollen allergen extract', 'interventionNames': ['Other: Grass pollen allergen extract']}], 'interventions': [{'name': 'Grass pollen allergen extract', 'type': 'OTHER', 'description': 'Each subject will be challenged with a grass pollen allergen extract and with placebo.', 'armGroupLabels': ['Grass pollen allergen extract']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['measurement of mediators in biological fluids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Cindy Barnig', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}