{"doc_desc":{"title":"Study of PROXimology in seveRe persistent Asthma","idno":"FRESH-PEF175-en","producers":[{"name":"Anne PONTHIEUX","affiliation":"NOVARTIS PHARMA SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF175-en","IDno":{"metadata_no":[{"agency":"PEF","code":"175"},{"agency":"FReSH","code":"FRESH-PEF175"}]},"title":"Study of PROXimology in seveRe persistent Asthma","alternate_title":"PROXAIR"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Anne;PONTHIEUX","PILabo":"Novartis Pharma \/ Direction Relations \u00c9conomiques et Institutionnelles","affiliationName":"NOVARTIS PHARMA SAS","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"076037657","role":"pi id"},{"title":"SIREN","uri":"410349070","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"anne.ponthieux@novartis.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"anne.ponthieux@novartis.com","type":"contact","affiliationName":"NOVARTIS PHARMA SAS","contactPointLabo":"","extlink":[{"uri":"410349070","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"asthma control quality of life spouse"}],"topics":[{"topic":"Pulmonary medicine","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":"Asthma","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1656445230","title":"CIM-11"}]}],"purpose":"Assess physical, psychic and socio-economic impact on patients and spouse of severe persistent asthma treated with high-dose inhaler steroids and long-acting \u00df2 agonists (LABA), according to the asthma control level","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient inclusion Criteria :  - Ambulatory patients, able to cooperate, of either sex, at least 18 years of age. \",\n    \"clusion_E\": \"micronized forms in metered-dose inhalers,\u2265800 \u00b5g\\\/d of beclometasone dipropionate in micronized form in metered-dose inhalers or \u2265800 \u00b5g\\\/j of budesonide or \u2265500 \u00b5g\\\/d of fluticasone propionate) and of inhaled long-acting \u00df2 agonists, administered:either in the form of two specialties using one or two of the following inhalers: Aerolizer\u00ae, standard metered-dose inhaler, Autohaler\uf0d4, Diskus\u00ae, Turbuhaler\u00ae,or in the form of a fixed association using one of the following inhalers: standard metered-dose inhaler, Diskus\u00ae, Turbuhaler\u00ae. - Patients with FEV measurement in the previous month. - Patients who brought their inhaled steroid treatment and inhaled long-acting \u00df2-agonist at the time of consultation. - Patients in couple whether or not married - Patients and relatives agree to participatePatientCriteria :- Patients with a non-asthmatic OCPD. - Patients who had inhaled steroids or lLABA treatment change in the previous three months (add-on or change of drug, posology change). - Patients and relatives refusing to participate to the study - Parents\\\/ those close unable to complete a self-questionnaire. - Patients who do not live as a couple\"\n}","data_kind":"['Participant-reported health data']","quality_statement":{"standards":[{"name":"['GINA classification']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"280"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"No","contributorName":"Anne PONTHIEUX","contributorAffiliation":"NOVARTIS PHARMA SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"self-questionnaire filled in at home and returned by mail","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"The study was carried out with a representative sample of pneumologist doctors with a hospital activity (exclusive or mixed) or with a solely liberal activity. The study was proposed by letter to all pneumologists exercising in France: 2089 pneumologists with hospital activity (exclusive or mixed) and 657 liberal pneumologists (Source: TVF, 4 January 2006)."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}