Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02507635
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2015-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory H1 Antihistamines Allergic Rhinitis
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': 'C472067', 'term': 'levocetirizine'}, {'id': 'C121345', 'term': 'desloratadine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of H1 antihistamines (patients evaluation)', 'timeFrame': '4 weeks', 'description': 'patients evaluation before and after 4-weeks treatment'}], 'secondaryOutcomes': [{'measure': 'asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)', 'timeFrame': '1.5 years', 'description': 'incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cytokines', 'persistent allergic rhinitis', 'H1 antihistamines'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '26740893', 'type': 'DERIVED', 'citation': 'Bocsan CI, Bujor AI, Miron N, Vesa SC, Deleanu D, Buzoianu AD. In Vivo Anti-Inflammatory Effect of H1 Antihistamines in Allergic Rhinitis: A Randomized Clinical Trial. Balkan Med J. 2015 Oct;32(4):352-8. doi: 10.5152/balkanmedj.2015.15884. Epub 2015 Oct 1.'}]}, 'descriptionModule': {'briefSummary': "The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.", 'detailedDescription': "Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.\n\nWe evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.\n\nEighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.\n\nThe clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.\n\nEach symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).\n\nA TSS\\<6 means a mild rhinitis, while a TSS\\> 6 represented a moderate severe one.\n\nThe patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma.\n\nThe biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha.\n\nClinical and biological evaluation were performed before and after treatment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persistent allergic rhinitis\n\nExclusion Criteria:\n\n* the presence of asthma or nasal polyps,\n* acute and chronic upper respiratory infections,\n* administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.'}, 'identificationModule': {'nctId': 'NCT02507635', 'briefTitle': 'Anti-inflammatory H1 Antihistamines Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis', 'orgStudyIdInfo': {'id': '535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'healthy volunteers', 'description': 'healthy volunteers'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Desloratadine', 'description': 'patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks', 'interventionNames': ['Drug: Desloratadine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levocetirizine', 'description': 'patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks', 'interventionNames': ['Drug: Levocetirizine']}], 'interventions': [{'name': 'Levocetirizine', 'type': 'DRUG', 'otherNames': ['Xyzal'], 'description': 'administration of Levocetirizine 5 mg/day for 4 weeks', 'armGroupLabels': ['Levocetirizine']}, {'name': 'Desloratadine', 'type': 'DRUG', 'otherNames': ['Aerius'], 'description': 'administration of Desloratadine 5 mg/day for 4 weeks', 'armGroupLabels': ['Desloratadine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Stefan Cristian Vesa', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}