{"doc_desc":{"title":"Etude transversale de PROXimologie dans l\u2019Asthme persIstant s\u00e9v\u00e8Re","idno":"FRESH-PEF175-fr","producers":[{"name":"Anne PONTHIEUX","affiliation":"NOVARTIS PHARMA SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF175-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"175"},{"agency":"FReSH","code":"FRESH-PEF175"}]},"title":"Etude transversale de PROXimologie dans l\u2019Asthme persIstant s\u00e9v\u00e8Re","alternate_title":"PROXAIR"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Anne;PONTHIEUX","firstname":"Anne","lastname":"PONTHIEUX","type":"investigator","extlink":[{"title":"SIREN","uri":"410349070","role":"organisation id"}],"email":"anne.ponthieux@novartis.com","affiliationName":"NOVARTIS PHARMA SAS","PILabo":"Novartis Pharma \/ Direction Relations \u00c9conomiques et Institutionnelles","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070"}]}]},"distribution_statement":{"contact":[{"name":"Anne;PONTHIEUX","lastname":"PONTHIEUX","firstname":"Anne","type":"contact","email":"anne.ponthieux@novartis.com","affiliationName":"NOVARTIS PHARMA SAS","contactPointLabo":"","extlink":[{"uri":"410349070","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"contr\u00f4le de l'asthme? qualit\u00e9 de vie? conjoint"}],"topics":[{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"Asthme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1656445230","title":"CIM-11"}]}],"purpose":"Etudier, en fonction du contr\u00f4le ou non de l\u2019asthme, le retentissement physique, psychique et socio-\u00e9conomique de l\u2019asthme persistant s\u00e9v\u00e8re trait\u00e9 par cortico\u00efde inhal\u00e9 \u00e0 forte dose et \u00df2 agoniste de longue dur\u00e9e d\u2019action (LDA), sur les patients et leur conjoint (personne vivant en couple mari\u00e9 ou non).","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d\u2019inclusion des patients :  - Patients ambulatoires, dispos\u00e9s \u00e0 coop\u00e9rer, de l'un ou l'autre sexe, \u00e2g\u00e9s d\u2019au moins 18 ans. - Patients pr\u00e9sentant un asthme persistant s\u00e9v\u00e8re recevant depuis au moins trois mois un traitement continu et stable par cortico\u00efde inhal\u00e9 \u00e0 forte dose (sup\u00e9rieur ou \u00e9gal \u00e0 1 000 \u00b5g\\\/j de dipropionate de b\u00e9clom\u00e9tasone hors formes micronis\u00e9es en a\u00e9rosol-doseur,  sup\u00e9rieur ou \u00e9gal \u00e0  800 \u00b5g\\\/j de dipropionate de b\u00e9clom\u00e9tasone sous forme micronis\u00e9e en a\u00e9rosol-doseur  ou sup\u00e9rieur ou \u00e9gal \u00e0  800 \u00b5g\\\/j de bud\u00e9sonide ou sup\u00e9rieur ou \u00e9gal \u00e0  500 \u00b5g\\\/j de propionate de fluticasone) et par \u00df2 agoniste de longue dur\u00e9e d\u2019action inhal\u00e9, administr\u00e9s : soit sous la forme de deux sp\u00e9cialit\u00e9s utilisant un ou deux des inhalateurs suivants :Aerolizer\u00ae, a\u00e9rosol-doseur standard, Autohaler, Diskus\u00ae, Turbuhaler\u00ae, soit sous la forme d\u2019une association fixe utilisant un des inhalateurs suivants : a\u00e9rosol-doseur standard, Diskus\u00ae, Turbuhaler\u00ae. - Patients ayant eu une mesure du VEMS au cours du mois pr\u00e9c\u00e9dent. - Patients ayant apport\u00e9 leur traitement cortico\u00efde inhal\u00e9 et \u00df2-agoniste de longue dur\u00e9e d\u2019action inhal\u00e9 lors de la consultation . - Patients vivant en couple mari\u00e9 ou non - Patients et entourage ayant accept\u00e9 de participer \",\n    \"clusion_E\": \"Patients atteints d\u2019une BPCO non asthmatique - Patients ayant eu une modification de leur traitement par cortico\u00efde inhal\u00e9 et par \u00df2 agoniste de longue dur\u00e9e d\u2019action inhal\u00e9s au cours des trois mois pr\u00e9c\u00e9dant l\u2019inclusion (ajout ou changement de produit, changement de posologie) - Patients et entourage refusant de participer \u00e0 l\u2019\u00e9tude - Patients \\\/ entourages inaptes \u00e0 compl\u00e9ter un auto-questionnaire - Patients ne vivant pas en couple\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"['classification GINA']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d&#x27;exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"280"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":false,"contributorName":"Anne PONTHIEUX","contributorAffiliation":"NOVARTIS PHARMA SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"auto-questionnaire compl\u00e9t\u00e9 au domicile et renvoy\u00e9 par voie postale","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"L\u2019\u00e9tude a \u00e9t\u00e9 r\u00e9alis\u00e9e aupr\u00e8s d\u2019un \u00e9chantillon repr\u00e9sentatif de m\u00e9decins pneumologues \u00e0 activit\u00e9 hospitali\u00e8re (exclusive ou mixte) ou \u00e0 activit\u00e9 uniquement lib\u00e9rale. L\u2019\u00e9tude a \u00e9t\u00e9 propos\u00e9e par courrier \u00e0 l\u2019ensemble des pneumologues exer\u00e7ant en France : 2089 pneumologues \u00e0 activit\u00e9 hospitali\u00e8re (exclusive ou mixte) et 657 pneumologues lib\u00e9raux (Source TVF, 4 janvier 2006)."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}