Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-03-15 @ 8:28 PM
Study NCT ID:
NCT01949428
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
House Dust Mite Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-14', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2013-09-20', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HDM Allergy', 'Rhinoconjunctivitis'], 'conditions': ['Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis', 'detailedDescription': 'House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.\n\nThe proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18-65 years\n* A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.\n* Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.\n* Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.\n* Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.\n* Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.\n\nExclusion Criteria:\n\n* Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.\n* Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening'}, 'identificationModule': {'nctId': 'NCT01949428', 'briefTitle': 'House Dust Mite Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Circassia Limited'}, 'officialTitle': 'A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'TH003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HDM-Induced Rhinoconjunctivitis Subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4Z 3E7', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pharm-Olam', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Circassia Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pharm-Olam International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}