Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-26 @ 5:47 AM
Study NCT ID:
NCT01535118
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2012-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Survey of Adults and Children With Allergic Rhinoconjunctivitis (MK-7243-021)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'No formal reporting or recording of adverse events was conducted during this observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'classes': [{'title': 'Nasal congestion or stuffed nose', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Runny nose', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Postnasal drip', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Nasal itching', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Red or itchy eyes', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Facial pain or pressure', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Throat itching', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Repeated sneezing', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who responded to the survey.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who responded to the survey.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'classes': [{'title': 'Prescription medications', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Over-the-counter medications', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who responded to the survey.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Immunotherapy to Treat ARC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'classes': [{'title': 'Subcutaneous allergy shots', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Sublingual allergy drops', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who responded to the survey.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who responded to the survey, received immunotherapy (allergy shots) and had not taken over-the-counter allergy medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who responded to the survey and received allergy shots.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults and Children With Allergic Rhinoconjunctivitis (ARC)', 'description': 'Adults and children with ARC who complete the survey'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2765'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2765'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A national probablility sample of 2765 adults \\& children (age 5+) who had ever been diagnosed with hay fever, allergic rhinitis, rhinoconjunctivitis, nasal allergies or eye allergies \\& had nasal allergy symptoms in the past 12 months or had taken prescription medicine for allergies were interviewed by telephone about their condition \\& treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults and Children With ARC', 'description': 'Adults and children with ARC who complete the survey'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '5 to 11 years of age', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}, {'title': '12 to 17 years of age', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}]}]}, {'title': '18 to 24 years of age', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}]}]}, {'title': '25 to 34 years of age', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}]}]}, {'title': '35 to 44 years of age', 'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}]}]}, {'title': '45 to 54 years of age', 'categories': [{'measurements': [{'value': '491', 'groupId': 'BG000'}]}]}, {'title': '55 to 64 years of age', 'categories': [{'measurements': [{'value': '515', 'groupId': 'BG000'}]}]}, {'title': '65+ years of age', 'categories': [{'measurements': [{'value': '597', 'groupId': 'BG000'}]}]}, {'title': "Don't Know/Refused", 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '581', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '333', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1851', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2765}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2012-02-14', 'resultsFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-09', 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated.'}, {'measure': 'Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated.'}, {'measure': 'Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated.'}, {'measure': 'Percentage of Participants Who Received Immunotherapy to Treat ARC', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated.'}, {'measure': 'Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma', 'timeFrame': 'Within 12 months prior to survey', 'description': 'Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergies', 'Immunotherapy'], 'conditions': ['Allergic Rhinoconjunctivitis']}, 'referencesModule': {'references': [{'pmid': '24679733', 'type': 'RESULT', 'citation': 'Blaiss MS, Dykewicz MS, Skoner DP, Smith N, Leatherman B, Craig TJ, Bielory L, Walstein N, Allen-Ramey F. Diagnosis and treatment of nasal and ocular allergies: the Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys. Ann Allergy Asthma Immunol. 2014 Apr;112(4):322-8.e1. doi: 10.1016/j.anai.2014.02.006.'}]}, 'descriptionModule': {'briefSummary': 'This study will gather information on allergic rhinoconjunctivitis from surveys completed by adults and children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and children with ARC in the United States.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with hay fever, rhinitis or nasal and/or eye allergies and display symptoms of sneezing, itching, watery eyes, nasal congestion, or other nasal or eye allergy symptoms over the past 12 months OR take any medication for their hay fever, rhinitis, nasal or eye allergies\n* 5 years of age or older\n* Have a telephone\n\nExclusion Criteria:\n\n* If less than 18 years old and there is no adult available that is knowledgeable about the participant's health"}, 'identificationModule': {'nctId': 'NCT01535118', 'acronym': 'AIRS', 'briefTitle': 'A Survey of Adults and Children With Allergic Rhinoconjunctivitis (MK-7243-021)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'National Allergies, Immunotherapy and RhinoConjunctivitis Survey in America', 'orgStudyIdInfo': {'id': '7243-021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults and Children with Allergic Rhinoconjunctivitis (ARC)', 'description': 'Adults and children with ARC who complete the survey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}