Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT03157505
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'area under the curve (AUC)', 'timeFrame': '24 months', 'description': 'area under the curve (AUC) for the combined symptom and medication scores (SMS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis', 'Allergic Reaction']}, 'referencesModule': {'references': [{'pmid': '17337294', 'type': 'BACKGROUND', 'citation': 'Rondon C, Romero JJ, Lopez S, Antunez C, Martin-Casanez E, Torres MJ, Mayorga C, R-Pena R, Blanca M. Local IgE production and positive nasal provocation test in patients with persistent nonallergic rhinitis. J Allergy Clin Immunol. 2007 Apr;119(4):899-905. doi: 10.1016/j.jaci.2007.01.006. Epub 2007 Mar 2.'}, {'pmid': '29273130', 'type': 'DERIVED', 'citation': 'Bozek A, Kolodziejczyk K, Jarzab J. Efficacy and safety of birch pollen immunotherapy for local allergic rhinitis. Ann Allergy Asthma Immunol. 2018 Jan;120(1):53-58. doi: 10.1016/j.anai.2017.10.009.'}]}, 'descriptionModule': {'briefSummary': 'Local allergic rhinitis (LAR) is relatively new disease. The question of effect of allergen specific immunotherapy on LAR is open. The randomized, double blind placebo controlled trial of birch subcutaneous AIT on LAR were performed in twenty eight patients. The therapy was performed during 24 months in proportion 15 patients with AIT and 13 placebo. The primary endpoint was decreased of symptoms medication score (SMS). Additionally monitoring serum specific IgE, specific IgG4 and nasal specific IgE (nsIgE) to Bet v1 and parameters of safety and quality of life were provided.', 'detailedDescription': 'Local allergic rhinitis (LAR) is still an under diagnosed and under treated disease. It is characterised by local production of IgE during natural exposure to aeroallergens. These patients have negative skin prick tests and serum-specific IgEs but have positive nasal provocation tests for aeroallergens. More than 50% of patients with chronic non-allergic rhinitis may have a problem with lack of LAR diagnosis. Misdiagnosis can lead to mistakes in the treatment as well as inefficiencies.\n\nBesides on only local IgE-mediated reaction, allergen immunotherapy (AIT) could be a potential way of treatment such patients. However, there are only sufficient data that the AIT is effective in allergic rhinoconjunctivitis and asthma to pollens and house dust mites and some animal.\n\nThe aim of this study was to assess the safety and efficacy of AIT for birch pollen allergens in patients with local allergic rhinitis and a confirmed birch pollen allergy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* well document symptoms of rhinitis during birch pollen season\n* positive nasal provocation test to birch\n* negative results of skin prick tests to inhalant allergen including: D. pteronyssius, D. farinae, grass pollen, birch, hazel, alder Alternaria, and cat.\n* negative results of serum total and allergen specific IgE against mentioned allergens.\n\nExclusion Criteria:\n\n* diagnosis of bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases. All subjects were required to abstain from anti-allergy drugs and glucocorticoid nasal drops for at least 6 weeks prior to the start of the study.'}, 'identificationModule': {'nctId': 'NCT03157505', 'acronym': 'LARbirch', 'briefTitle': 'Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis', 'orgStudyIdInfo': {'id': '605060184JB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Purethal Birch immunotherapy', 'description': 'Purethat Birch intervention and symptomatic treatment for 24 months', 'interventionNames': ['Drug: Purethal Birch immunotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo and symptomatic treatment', 'description': 'placebo intervention and symtomatic treatment during 24 months', 'interventionNames': ['Other: Placebo and symptomatic treatment']}], 'interventions': [{'name': 'Purethal Birch immunotherapy', 'type': 'DRUG', 'otherNames': ['allergen specific immunotherapy'], 'description': 'Purethal birch was administered as perennial therapy: 24 months', 'armGroupLabels': ['Purethal Birch immunotherapy']}, {'name': 'Placebo and symptomatic treatment', 'type': 'OTHER', 'description': 'symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection', 'armGroupLabels': ['placebo and symptomatic treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andreas Fisher', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Outpatient Clinic Allergy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Andrzej Bozek', 'investigatorAffiliation': 'Medical University of Silesia'}}}}