[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibrosing-interstitial-lung-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibrosing-interstitial-lung-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100621085","phase-3-a-study-to-find-out-how-nerandomilast-is-tolerated-handled-by-the-body-and-if-it-helps-children-and-adolescents-with-interstitial-lung-disease-fibroneer-child-100621085",false,"NCT07366034","A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)","A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)","Inclusion Criteria:\n\n* Children and adolescents 2 to \\\u003C18 years old at Visit 2.\n* Participants with evidence of fibrosing ILD on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.\n* For children ≥6 years: Participants with forced vital capacity (FVC) % predicted ≥25% at Visit 2.\n* Participants with clinically significant fibrosing ILD at Visit 2, as assessed by the investigator based on any of the following:\n\n  * Fan score ≥3, or\n  * Documented evidence of clinical progression over time based on either\n\n    * a 5-10% relative decline in FVC % predicted accompanied by worsening symptoms, or\n    * a ≥10% relative decline in FVC % predicted, or\n    * increased fibrosis on HRCT, or\n    * other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity).\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous treatment with nerandomilast.\n* Participants treated with other oral\u002Fsystemic PDE4 and non-selective PDE inhibitors within 30 days before Visit 1.\n* Participants treated with pirfenidone in the 8 weeks prior to Visit 1.\n* Unstable pulmonary arterial hypertension (PAH).\n* Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period.\n* Any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) in the past (lifetime).\n* Any suicidal ideation of type 4 or 5 on the columbia suicidal severity rating scale (C-SSRS) in the past 3 months at Visit 1 or at Visit 2 (i.e. active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent, and plan).\n* Participants with clinically significant depression symptoms defined as the short version of mood and feeling questionnaire (SMFQ) score ≥8.\n\nFurther exclusion criteria apply.","ALL","2 Years","17 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD.\n\nFor participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine.\n\nParticipants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part.\n\nYoung participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years.\n\nDepending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents.",[27],"Fibrosing Interstitial Lung Disease","NOT_YET_RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":21},"2026-07-27",{"date":36,"type":21},"2031-04-14",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",48,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100581799","prospective-cohort-of-patients-with-fibrosing-interstitial-lung-disease-admitted-for-acute-respiratory-failure-100581799","NCT06855004","Prospective Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted for Acute Respiratory Failure","Prospective Multicenter Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted to Intensive Care or Critical Care Units for Acute Respiratory Failure","PIDREA","Inclusion Criteria:\n\n1. Hospitalization in intensive care for acute respiratory failure\n2. Requirement for standard oxygen therapy with an O2 flow rate \\> 6 l\u002Fmin, high-flow oxygen therapy, or mechanical ventilation (non-invasive or invasive)\n3. Age ≥ 18 years\n4. Patient (male or female) with chronic interstitial lung disease (ILD)\n\n   1. Diagnosis of chronic ILD confirmed by a multidisciplinary discussion (MDD) prior to admission to intensive care, or\n   2. Diagnosis of chronic ILD made during the intensive care stay due to the acute episode and confirmed by an expert opinion.\n\nExclusion Criteria:\n\n1. Patient under legal guardianship or with restricted freedom\n2. Patient hospitalized for psychiatric reasons or with a severe psychiatric illness causing a disability, subject to legal protection measures\n3. Pregnant woman\n4. Patient already enrolled in the study","18 Years",{"count":51,"type":21},250,"OBSERVATIONAL","This prospective, multicenter study focuses on patients with fibrosing interstitial lung diseases (ILD) admitted to intensive care units (ICUs) for acute respiratory failure (ARF). ILD encompasses a group of heterogeneous disorders characterized by progressive fibrotic and inflammatory damage to the lung interstitium, often resulting in chronic respiratory failure. Acute respiratory failure in these patients is a severe and frequent complication caused by various factors, including infections, pulmonary embolism, cardiac decompensation, or acute exacerbation of fibrosis. Despite advances in treatment, ICU management of these patients remains a clinical and ethical challenge due to high mortality rates and limited evidence-based guidance.\n\nThe study's primary objective is to assess 6-month survival following ICU admission for ARF in ILD patients. Secondary objectives include identifying prognostic factors for mortality, characterizing ICU and hospital mortality rates, and evaluating the use of organ support measures (e.g., oxygen therapy, invasive or non-invasive mechanical ventilation). Additionally, the study will examine the frequency of lung transplantation, acquired ICU infections, and decisions to limit or withdraw life-sustaining therapies.\n\nImportantly, this research aims to address a significant gap in current knowledge by building a large, descriptive, prospective cohort of ILD patients. A critical aspect of the study is the evaluation of patients' quality of life (QoL) six months after ICU discharge, using a dedicated questionnaire. This information will provide essential insights into the long-term benefits of ICU care for these patients, complementing survival data with QoL outcomes to better guide clinical decision-making and improve patient-centered care.",[27],[56,57,58],"fibrosing interstitial lung disease","intensive care or critical care units","mortality","RECRUITING","2025-02-28",{"date":62,"type":32},"2025-03-03",{"date":64,"type":32},"2025-01-28",{"date":66,"type":21},"2030-10-28",{"name":68,"class":69},"Assistance Publique - Hôpitaux de Paris","OTHER",1]