[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491120":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":45,"responsibleParty":352,"collaborators":26,"id":354,"slug":355,"hasResults":356,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":356,"sex":362,"minAge":363,"maxAge":26,"enrollmentInfo":364,"targetDuration":26,"studyType":367,"phases":368,"briefSummary":370,"conditions":371,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},{"fullName":5,"class":6},"Fondation Hôpital Saint-Joseph","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MethylPrednisone\u002FPrednisone","EXPERIMENTAL","* Day 1, 2 and 3: Intravenous Methylprednisolone 10 mg\u002Fkg\u002Fd (without exceeding 1000 mg\u002Fd) Vials of injectable solution of methylprednisolone® are diluted in 100 ml of NaCl 0.9% or G5%. Perfusion duration is between 20 to 30 minutes. The commercialized form for methylprednisolone injectable solution is not imposed and is taken from the stock of each pharmacy of the participating centers.\n* From day 4 to Day 30: Oral Prednisone slow tappering\n\n  * 1 mg\u002Fkg\u002Fd for 7 days\n  * 0.5 mg\u002Fkg\u002Fd for 7 days\n  * 0.25 mg\u002Fkg\u002Fd for 7 days,\n  * 10 mg\u002Fd until Day 30. For 10mg\u002Fkg, 1 mg\u002Fkg, 0.5 mg\u002Fkg, 0.25 mg\u002Fkg; rounding to 5 decimal lower if decimal ≤ 7 and the top ten if decimal ≥ 8.",[13],"Drug: Methylprednisone\u002FPrednisone",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","* Day 1, 2 and 3: Intravenous Methylprednisolone-Placebo\n* From Day 4 to Day 30: Oral Prednisone-Placebo",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methylprednisone\u002FPrednisone","Patients will be enrolled during their hospitalization in pneumology department, as part of current practice, within 7 days of the screening visit. The investigator will perform randomization by connecting to the eCRF, randomization be stratified for the severity of IPF and the treatment with antifibrotic therapy (Nintedanib or Pirfenidone) (yes\u002Fno).\n\nIf patient is randomized in Glucocorticoids Group:\n\n* Day 1, 2 and 3: Intravenous Methylprednisolone 10 mg\u002Fkg\u002Fd (without exceeding 1000 mg\u002Fd). Vials of injectable solution of methylprednisolone® are diluted in 100 ml of NaCl 0.9% or G5%. Perfusion duration is between 20 to 30 minutes.\n* From day 4 to Day 30: Oral Prednisone slow tappering\n\n  * 1 mg\u002Fkg\u002Fd for 7 days\n  * 0.5 mg\u002Fkg\u002Fd for 7 days\n  * 0.25 mg\u002Fkg\u002Fd for 7 days,\n  * 10 mg\u002Fd until Day 30. For 10mg\u002Fkg, 1 mg\u002Fkg, 0.5 mg\u002Fkg, 0.25 mg\u002Fkg; rounding to 5 decimal lower if decimal ≤ 7 and the top ten if decimal ≥ 8.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Patients will be enrolled during their hospitalization in pneumology department, as part of current practice, within 7 days of the screening visit. The investigator will perform randomization by connecting to the eCRF, randomization be stratified for the severity of IPF and the treatment with antifibrotic therapy (Nintedanib or Pirfenidone) (yes\u002Fno).\n\nIf patient is randomized in Placebo Group:\n\nDay 1, 2 and 3: Intravenous Methylprednisolone-Placebo From Day 4 to Day 30: Oral Prednisone-Placebo The Methylprednisolone-Placebo corresponds to 100 ml of NaCl 0.9 % or G5%. Perfusion duration is between 20 to 30 minutes.\n\nFor the Prednisone-Placebo, the placebo was an oral solution formulated with a bittering agent (pharmaceutical excipient). Specifically, in place of prednisone, sucrose octaacetate (defined as a GRAS-'Generally Recognized as Safe' excipient by the EMA) was used at 5 mg\u002FmL.",[15],[31],{"name":32,"affiliation":5,"role":33},"Jean-Marc NACCACHE","STUDY_DIRECTOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Jean-Marc NACCACHE, MD","CONTACT","144126747","+33","jmnaccache@ghpsj.fr",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Helene BEAUSSIER, PharmD, PhD","144127883","crc@ghpsj.fr",[46,61,72,84,95,106,117,128,139,150,161,172,183,194,205,216,227,238,246,254,262,270,278,286,297,308,319,330,341],{"facility":47,"status":48,"city":49,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"CHU ANgers","RECRUITING","Angers","France","FR",{"type":53,"coordinates":54},"Point",[55,56],-0.55202,47.47156,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":26,"phoneExt":26,"email":26},"Frederic GAGNADOUX",{"facility":62,"status":48,"city":63,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CHU de Besancon","Besançon",{"type":53,"coordinates":65},[66,67],6.01815,47.24878,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":26,"phoneExt":26,"email":26},"Mathilde DUPREZ, MD",{"facility":73,"status":74,"city":75,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hôpital Avicenne","NOT_YET_RECRUITING","Bobigny",{"type":53,"coordinates":77},[78,79],2.45012,48.90982,{"lat":79,"lon":78},[82],{"name":83,"role":37,"phone":26,"phoneExt":26,"email":26},"Hilario NUNES, MD",{"facility":85,"status":48,"city":86,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"CHU BOrdeaux","Bordeaux",{"type":53,"coordinates":88},[89,90],-0.58046,44.84124,{"lat":90,"lon":89},[93],{"name":94,"role":37,"phone":26,"phoneExt":26,"email":26},"Elodie BLANCHARD, MD",{"facility":96,"status":48,"city":97,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"CHU Caen","Caen",{"type":53,"coordinates":99},[100,101],-0.35912,49.18585,{"lat":101,"lon":100},[104],{"name":105,"role":37,"phone":26,"phoneExt":26,"email":26},"Emmanuel BERGOT, MD",{"facility":107,"status":74,"city":108,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU Clermont-Ferrand","Clermont-Ferrand",{"type":53,"coordinates":110},[111,112],3.08682,45.77969,{"lat":112,"lon":111},[115],{"name":116,"role":37,"phone":26,"phoneExt":26,"email":26},"Camille ROLLAND DEBORD, MD",{"facility":118,"status":48,"city":119,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"CHIC","Créteil",{"type":53,"coordinates":121},[122,123],2.46569,48.79266,{"lat":123,"lon":122},[126],{"name":127,"role":37,"phone":26,"phoneExt":26,"email":26},"Quentin GIBIOT, MD",{"facility":129,"status":48,"city":130,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"CHU de Dijon","Dijon",{"type":53,"coordinates":132},[133,134],5.01391,47.31344,{"lat":134,"lon":133},[137],{"name":138,"role":37,"phone":26,"phoneExt":26,"email":26},"Philippe BONNIAUD, MD",{"facility":140,"status":74,"city":141,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"CHU Grenoble","Grenoble",{"type":53,"coordinates":143},[144,145],5.71479,45.17869,{"lat":145,"lon":144},[148],{"name":149,"role":37,"phone":26,"phoneExt":26,"email":26},"Sebastien QUETANT, MD",{"facility":151,"status":74,"city":152,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"CHRU Lille","Lille",{"type":53,"coordinates":154},[155,156],3.05512,50.63391,{"lat":156,"lon":155},[159],{"name":160,"role":37,"phone":26,"phoneExt":26,"email":26},"Victor VALENTIN, MD",{"facility":162,"status":48,"city":163,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Hospices Civils de Lyon","Lyon",{"type":53,"coordinates":165},[166,167],4.84789,45.74906,{"lat":167,"lon":166},[170],{"name":171,"role":37,"phone":26,"phoneExt":26,"email":26},"Vincent COTTIN, MD",{"facility":173,"status":48,"city":174,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Hôpital Nord","Marseille",{"type":53,"coordinates":176},[177,178],5.38107,43.29695,{"lat":178,"lon":177},[181],{"name":182,"role":37,"phone":26,"phoneExt":26,"email":26},"Martine REAYNAUD GAUBERT, MD",{"facility":184,"status":74,"city":185,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"CHU de Montpellier","Montpellier",{"type":53,"coordinates":187},[188,189],3.87635,43.61093,{"lat":189,"lon":188},[192],{"name":193,"role":37,"phone":26,"phoneExt":26,"email":26},"Arnaud BOURDIN, MD",{"facility":195,"status":48,"city":196,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"CHU Nancy","Nancy",{"type":53,"coordinates":198},[199,200],6.18496,48.68439,{"lat":200,"lon":199},[203],{"name":204,"role":37,"phone":26,"phoneExt":26,"email":26},"Anne GUILLAUMOT, MD",{"facility":206,"status":74,"city":207,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"CHU de Nantes","Nantes",{"type":53,"coordinates":209},[210,211],-1.55336,47.21725,{"lat":211,"lon":210},[214],{"name":215,"role":37,"phone":26,"phoneExt":26,"email":26},"Stéphanie DIROU, MD",{"facility":217,"status":74,"city":218,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"CHU Nice","Nice",{"type":53,"coordinates":220},[221,222],7.26608,43.70313,{"lat":222,"lon":221},[225],{"name":226,"role":37,"phone":26,"phoneExt":26,"email":26},"Sylvie LEROY, MD",{"facility":228,"status":48,"city":229,"state":26,"zip":230,"country":50,"countryCode":51,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Hôpital Paris Saint-Joseph","Paris","75014",{"type":53,"coordinates":232},[233,234],2.3488,48.85341,{"lat":234,"lon":233},[237],{"name":36,"role":37,"phone":26,"phoneExt":26,"email":26},{"facility":239,"status":48,"city":229,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":240,"geoPoint":242,"contacts":243},"Hôpital Bichat",{"type":53,"coordinates":241},[233,234],{"lat":234,"lon":233},[244],{"name":245,"role":37,"phone":26,"phoneExt":26,"email":26},"Bruno CRESTANI, MD",{"facility":247,"status":48,"city":229,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":248,"geoPoint":250,"contacts":251},"Hôpital Européen Georges Pompidou",{"type":53,"coordinates":249},[233,234],{"lat":234,"lon":233},[252],{"name":253,"role":37,"phone":26,"phoneExt":26,"email":26},"Jean PASTRE, MD",{"facility":255,"status":74,"city":229,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":256,"geoPoint":258,"contacts":259},"Hôpital FOCH",{"type":53,"coordinates":257},[233,234],{"lat":234,"lon":233},[260],{"name":261,"role":37,"phone":26,"phoneExt":26,"email":26},"Alexandre CHABROL, MD",{"facility":263,"status":48,"city":229,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":264,"geoPoint":266,"contacts":267},"Hôpital Kremiln Bicetre",{"type":53,"coordinates":265},[233,234],{"lat":234,"lon":233},[268],{"name":269,"role":37,"phone":26,"phoneExt":26,"email":26},"David MONTANI, MD",{"facility":271,"status":74,"city":229,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":272,"geoPoint":274,"contacts":275},"Hôpital Saint-Louis",{"type":53,"coordinates":273},[233,234],{"lat":234,"lon":233},[276],{"name":277,"role":37,"phone":26,"phoneExt":26,"email":26},"Abdellatif TAZI, MD",{"facility":279,"status":48,"city":229,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":280,"geoPoint":282,"contacts":283},"Hôpital Tenon",{"type":53,"coordinates":281},[233,234],{"lat":234,"lon":233},[284],{"name":285,"role":37,"phone":26,"phoneExt":26,"email":26},"Jacques CADRANEL, MD",{"facility":287,"status":48,"city":288,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"CHU Reims","Reims",{"type":53,"coordinates":290},[291,292],4.02853,49.26526,{"lat":292,"lon":291},[295],{"name":296,"role":37,"phone":26,"phoneExt":26,"email":26},"Francois LEBARGY, MD",{"facility":298,"status":48,"city":299,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"CHU Rennes","Rennes",{"type":53,"coordinates":301},[302,303],-1.67431,48.11109,{"lat":303,"lon":302},[306],{"name":307,"role":37,"phone":26,"phoneExt":26,"email":26},"Stephane JOUNEAU, MD",{"facility":309,"status":74,"city":310,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"CHU Rouen","Rouen",{"type":53,"coordinates":312},[313,314],1.09932,49.44313,{"lat":314,"lon":313},[317],{"name":318,"role":37,"phone":26,"phoneExt":26,"email":26},"Stéphane DOMINIQUE, MD",{"facility":320,"status":74,"city":321,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"CHU Strasbourg","Strasbourg",{"type":53,"coordinates":323},[324,325],7.74553,48.58392,{"lat":325,"lon":324},[328],{"name":329,"role":37,"phone":26,"phoneExt":26,"email":26},"Sandrine HIRSCHI, MD",{"facility":331,"status":48,"city":332,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"CHU Toulouse","Toulouse",{"type":53,"coordinates":334},[335,336],1.44367,43.60426,{"lat":336,"lon":335},[339],{"name":340,"role":37,"phone":26,"phoneExt":26,"email":26},"Gregoire PREVOT, MD",{"facility":342,"status":74,"city":343,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"CHU Tours","Tours",{"type":53,"coordinates":345},[346,347],0.70398,47.39484,{"lat":347,"lon":346},[350],{"name":351,"role":37,"phone":26,"phoneExt":26,"email":26},"Thomas FLAMENT, MD",{"type":353,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100491120","phase-3-glucocorticoids-versus-placebo-for-the-treatment-of-acute-exacerbation-of-idiopathic-pulmonary-fibrosis-100491120",false,"NCT05674994","Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis","Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial","EXAFIP2","Inclusion Criteria:\n\n1. Patient is ≥ 18 years of age\n2. IPF or IPF (likely) diagnosis defined on 2018 international recommendations\n3. Definite or suspected Acute Exacerbation defined by the international working group criteria after exclusion of alternative diagnoses of acute worsening\n\n   \\*The criteria of IPF-AE are as follows:\n   * Previous or concurrent diagnosis of IPF (a)\n   * Acute worsening or development of dyspnea typically \\\u003C 1-month duration\n   * Computed tomography with new bilateral ground-glass opacity and\u002For consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (b)\n   * Deterioration not fully explained by cardiac failure or fluid overload Patients who fail to meet all 4 criteria due to missing computed tomography should be considered as having \"suspected Acute Exacerbation\".\n\n     1. If the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and\u002For histopathologic changes consistent with usual interstitial pneumonia pattern on the current evaluation.\n     2. If no previous computed tomography is available, the qualifier \"new\" can be dropped from the third criterion.\n4. For women of childbearing age: efficient contraception for the duration of the study\\*\n\n   \\*Effective contraception is defined as any contraceptive method that is used consistently and appropriately and has a low failure rate (i.e., less than 1% per year)\n5. Affiliation to the social security\n6. Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form\n\nExclusion Criteria:\n\n1. Identified etiology for acute worsening (i.e.: infectious disease)\n2. Known hypersensitivity to glucocorticoids or to any component of the study treatment\n3. Patient requiring mechanical ventilation or already on mechanical ventilation\n4. Active bacterial, viral, fungal or parasitic infection. On swab collected, only positive for SARS-CoV-2, Influenzae A, Influenzae B and Respiratory Syncytial Virus (RSV) result, are considered active viral infection. The others viruses (i.e. Rhinovirus, Adenovirus…) are not considered to be responsible of pneumonia.\n5. Active cancer\n6. Patient on a lung transplantation waiting list\n7. Treatment with glucocorticoids \\> 1 mg\u002Fkg\u002Fd from more than 7 days in the last 15 days\n8. Patient participating to another interventional clinical trial\n9. Documented pregnancy or lactation\n10. Patient under tutorship or curatorship\n11. Patient deprived of liberty\n12. Patient under court protection","ALL","18 Years",{"count":365,"type":366},110,"ESTIMATED","INTERVENTIONAL",[369],"PHASE3","Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.",[372],"Acute Exacerbation of Idiopathic Pulmonary Fibrosis","2026-02-26",{"date":375,"type":376},"2026-03-02","ACTUAL",{"date":378,"type":376},"2023-10-26",{"date":380,"type":366},"2026-12-31",{"name":5,"class":6},29]