Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 10:13 AM
Study NCT ID:
NCT01247259
Status:
COMPLETED
Last Update Posted:
2010-11-24
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-22', 'studyFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total nasal symptom score (TNSS) and anti-allergic medication score (AMS)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic rhinitis', 'immunotherapy', 'sublingual'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic rhinitis. It is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. This study compared the efficacy of SLIT with standardized house dust mite extract in mono- and polysensitized allergic rhinitis patients.\n\nPatients who were sensitized to house dust mites and treated with SLIT for house dust mites for at least 1 year between November 2007 and March 2010 were included. The mono-allergen sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was defined as the patients who were simultaneously sensitized to house dust mites and other allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy. Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea, sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.\n\nThis study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups, while the change in the TNSS did not differ significantly between the groups. The anti-allergic medication scores also decreased significantly in both groups, but there was no significant difference between the groups.\n\nIn polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in both nasal symptoms and rescue medication scores to those in monosensitized patients, regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized allergic rhinitis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '53 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had sneezing, itching, rhinorrhea, and nasal congestion with or without eye symptoms\n* patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df), as confirmed by skin prick testing (A/H ratio ≥ 1) or MAST\n\nExclusion Criteria:\n\n* Patients who had immunotherapy in the preceding 3 years\n* Patients who had systemic immunological disorders'}, 'identificationModule': {'nctId': 'NCT01247259', 'briefTitle': 'Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy of Sublingual Immunotherapy With House Dust Mite Extract in Poly-allergen-sensitized Allergic Rhinitis Patients', 'orgStudyIdInfo': {'id': 'SLIT-POLYSENSITIZATION'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SLIT-mono', 'interventionNames': ['Drug: Pangramin®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLIT-poly', 'interventionNames': ['Drug: Pangramin®']}], 'interventions': [{'name': 'Pangramin®', 'type': 'DRUG', 'description': 'During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase.', 'armGroupLabels': ['SLIT-mono', 'SLIT-poly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Otorhinolaryngology, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong-Young Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}}}}