Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01350661
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Five Asthma Control Questionnaires
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-07', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of asthma control', 'timeFrame': '1 day', 'description': 'The five questionnaires are completed succesively on the same time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Questionnaires'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '23890766', 'type': 'DERIVED', 'citation': 'Vermeulen F, de Meulder I, Paesmans M, Muylle I, Bruyneel M, Ninane V. Asthma control measurement using five different questionnaires: a prospective study. Respir Med. 2013 Sep;107(9):1314-21. doi: 10.1016/j.rmed.2013.07.003. Epub 2013 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why.\n\nThe investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen at the consultation of pulmonology of a tertiary hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma confirmed by a pulmonologist\n* Patient have had a lung function testing on the same day than the questionnaires are fulfilled.\n* Age equal or upper than 18 years\n* Agreement to participate to this study\n\nExclusion Criteria:\n\n* Age under 18 years\n* Refusal to participate to this study'}, 'identificationModule': {'nctId': 'NCT01350661', 'briefTitle': 'Correlation Between Five Asthma Control Questionnaires', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Assessment of Correlation Between Five Asthma Control Questionnaires', 'orgStudyIdInfo': {'id': 'B07620109010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma control level assessment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU St Pierre; pulmonology department', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Inge Muylle', 'investigatorFullName': 'Dr. Inge Muylle', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}