Nctid:
NCT06229509
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D000029424", "term"=>"Pulmonary Disease, Chronic Obstructive"}, {"id"=>"D000004417", "term"=>"Dyspnea"}], "ancestors"=>[{"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000012120", "term"=>"Respiration Disorders"}, {"id"=>"D000012818", "term"=>"Signs and Symptoms, Respiratory"}], "browseLeaves"=>[{"id"=>"M11168", "name"=>"Lung Diseases", "asFound"=>"Pulmonary Disease", "relevance"=>"HIGH"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "asFound"=>"Obstructive Pulmonary Disease", "relevance"=>"HIGH"}, {"id"=>"M23449", "name"=>"Pulmonary Disease, Chronic Obstructive", "asFound"=>"Chronic Obstructive Pulmonary Disease", "relevance"=>"HIGH"}, {"id"=>"M28396", "name"=>"Sarcopenia", "relevance"=>"LOW"}, {"id"=>"M7591", "name"=>"Dyspnea", "asFound"=>"Dyspnea", "relevance"=>"HIGH"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M15623", "name"=>"Signs and Symptoms, Respiratory", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>26}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-08", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Variation in exercise-induced release of cytokines IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) between the two ventilatory conditions (sham and effective)", "timeFrame"=>"At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice"}, {"measure"=>"Variation in exercise-induced release of adipokines adiponectin and leptin concentrations (pg/mL) between the two ventilatory conditions (sham and effective)", "timeFrame"=>"At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice"}], "secondaryOutcomes"=>[{"measure"=>"For each ventilatory condition, study of correlation between dyspnea descriptors (Borg scale score, Multidimensional Dyspnea Profil score) and cytokines, adipokines and myokines plasma concentrations (pg/mL)", "timeFrame"=>"At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice"}, {"measure"=>"For each ventilatory condition, study of correlation between muscle mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).", "timeFrame"=>"At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice"}, {"measure"=>"For each ventilatory condition, study of correlation between fat mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).", "timeFrame"=>"At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Cytokines", "Myokines", "Adipokines", "Exercise", "Noninvasive Ventilation", "Sarcopenia"], "conditions"=>["Chronic Obstructive Pulmonary Disease Severe", "Dyspnea"]}, "descriptionModule"=>{"briefSummary"=>"Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality.\n\nCOPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority.\n\nIn patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea.\n\nOur research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance.\n\nThe ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient affiliated to a social security scheme.\n* Patient capable of giving free, informed, written and signed consent.\n* Male gender\n* Severe COPD (Chronic Obstructive Pulmonary Disease) diagnosed according to GOLD criteria, in a stable state, with a forced expiratory volume (FEV1) from 30 to 50% of the predicted value (measured within one year during respiratory function tests (RFT)\n* History of smoking \\>10 pack-years with cessation of smoking for more than 12 months.\n* Patient judged by the investigator to be able to tolerate inspiratory pressure during a preliminary cycling exercise test.\n\nExclusion Criteria:\n\n* Severe anxiety disorders, assessed by the STAY Y-B form questionnaire; a score above 65 indicates very high day-to-day anxiety.\n* Patient under guardianship/trusteeship/supervision of justice\n* Chronic hypercapnia at rest (CO2 arterial pressure ≥ 50mmHg)\n* Chronic use of non-invasive ventilation\n* Known pulmonary hypertension\n* Chronic administration of oral corticosteroids\n* Unstable heart disease"}, "identificationModule"=>{"nctId"=>"NCT06229509", "acronym"=>"CYTODINE", "briefTitle"=>"Study of the Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Clermont-Ferrand"}, "officialTitle"=>"Study of Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition", "orgStudyIdInfo"=>{"id"=>"AOI 2022 ROLLAND DEBORD"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Effective noninvasive ventilation", "description"=>"Alleviate dyspnea (lower Borg Score by 2 points)", "interventionNames"=>["Device: Effective noninvasive ventilation"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Sham noninvasive ventilation", "interventionNames"=>["Device: Sham noninvasive ventilation"]}], "interventions"=>[{"name"=>"Effective noninvasive ventilation", "type"=>"DEVICE", "description"=>"Noninvasive ventilation set to alleviate dyspnea Inspiratory aid set according to a preliminary test (aiming for a diminution of 2 points in Borg score)", "armGroupLabels"=>["Effective noninvasive ventilation"]}, {"name"=>"Sham noninvasive ventilation", "type"=>"DEVICE", "description"=>"Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea", "armGroupLabels"=>["Sham noninvasive ventilation"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Clermont-Ferrand", "country"=>"France", "contacts"=>[{"name"=>"Lise Laclautre", "role"=>"CONTACT", "email"=>"promo_interne_drci@chu-clermontferrand.fr", "phone"=>"0473751195"}, {"name"=>"Camille ROLLAND-DEBORD", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Frederic COSTES", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"CHU Clermont-Ferrand", "geoPoint"=>{"lat"=>45.77966, "lon"=>3.08628}}], "centralContacts"=>[{"name"=>"Lise Laclautre", "role"=>"CONTACT", "email"=>"promo_interne_drci@chu-clermontferrand.fr", "phone"=>"0473751195"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Clermont-Ferrand", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
