[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361292":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":22,"responsibleParty":149,"collaborators":153,"id":164,"slug":10,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":10,"eligibilityCriteria":168,"healthyVolunteers":165,"sex":169,"minAge":170,"maxAge":10,"enrollmentInfo":171,"targetDuration":174,"studyType":175,"phases":10,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Cantonal Hosptal, Baselland","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Severe Asthma",null,"All patients with severe asthma who will be treated in the participating centers should be continuously enrolled in the register.",[13],{"name":14,"affiliation":15,"role":16},"Jörg Leuppi","Kantonsspital Baselland Liestal","PRINCIPAL_INVESTIGATOR",[18],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","+41619252181","Joerg.leuppi@ksbl.ch",[23,41,53,65,77,89,101,113,125,137],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Cantonal Hospital Baselland Liestal","RECRUITING","Liestal","Basel-Landschaft","4410","Switzerland","CH",{"type":32,"coordinates":33},"Point",[34,35],7.73446,47.48455,{"lat":35,"lon":34},[38],{"name":39,"role":19,"phone":10,"phoneExt":10,"email":40},"Jörg Leuppi, Professor","joerg.leuppi@ksbl.ch",{"facility":42,"status":25,"city":43,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":44,"geoPoint":48,"contacts":49},"Universitätsklinik für Pneumologie, Inselspital","Bern",{"type":32,"coordinates":45},[46,47],7.44744,46.94809,{"lat":47,"lon":46},[50],{"name":51,"role":19,"phone":10,"phoneExt":10,"email":52},"Nikolay Pavlov, MD","nikolay.pavlov@insel.ch",{"facility":54,"status":25,"city":55,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Pneumologie, Kantonsspital Graubünden","Chur",{"type":32,"coordinates":57},[58,59],9.53287,46.84986,{"lat":59,"lon":58},[62],{"name":63,"role":19,"phone":10,"phoneExt":10,"email":64},"Thomas Rothe, MD","thomas.rothe@gmx.ch",{"facility":66,"status":25,"city":67,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Klinik für Pneumologie, Hochgebirgsklinik Davos","Davos",{"type":32,"coordinates":69},[70,71],9.83723,46.80429,{"lat":71,"lon":70},[74],{"name":75,"role":19,"phone":10,"phoneExt":10,"email":76},"Hans-Werner Duchna, Professor","hans-werner.duchna@hgk.ch",{"facility":78,"status":25,"city":79,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hôpitaux Universitaires Genève","Geneva",{"type":32,"coordinates":81},[82,83],6.14569,46.20222,{"lat":83,"lon":82},[86],{"name":87,"role":19,"phone":10,"phoneExt":10,"email":88},"Florian Charbonnier, MD","florian.charbonnier@hcuge.ch",{"facility":90,"status":25,"city":91,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Centre hospitalier universitaire vaudoise","Lausanne",{"type":32,"coordinates":93},[94,95],6.63282,46.516,{"lat":95,"lon":94},[98],{"name":99,"role":19,"phone":10,"phoneExt":10,"email":100},"Christophe Von Garnier, Professor","christophe.von-garnier@chuv.ch",{"facility":102,"status":25,"city":103,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Pneumologia, Ospedale Civico","Lugano",{"type":32,"coordinates":105},[106,107],8.96004,46.01008,{"lat":107,"lon":106},[110],{"name":111,"role":19,"phone":10,"phoneExt":10,"email":112},"Pietro Gianella, MD","pietro.gianella@eoc.ch",{"facility":114,"status":25,"city":115,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Klinik für Pneumologie und Schlafmedizin, Kantonsspital St.Gallen","Sankt Gallen",{"type":32,"coordinates":117},[118,119],9.37477,47.42391,{"lat":119,"lon":118},[122],{"name":123,"role":19,"phone":10,"phoneExt":10,"email":124},"Lucas Kern, MD","lukas.kern@kssg.ch",{"facility":126,"status":25,"city":127,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Hôpital du valais, sion","Sion",{"type":32,"coordinates":129},[130,131],7.35559,46.22739,{"lat":131,"lon":130},[134],{"name":135,"role":19,"phone":10,"phoneExt":10,"email":136},"Pierre-Olivier Bridevaux, Professor","pierre-olivier.bridevaux@hospitalvs.ch",{"facility":138,"status":25,"city":139,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Klinik für Pneumologie, Universitätsspital Zürich","Zurich",{"type":32,"coordinates":141},[142,143],8.55,47.36667,{"lat":143,"lon":142},[146],{"name":147,"role":19,"phone":10,"phoneExt":10,"email":148},"Christian Clarenbach, MD","christian.clarenbach@usz.ch",{"type":150,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Prof. Dr. Jörg Leuppi","Professor of Internal Medicine",[154,157,159,162],{"name":155,"class":156},"AstraZeneca","INDUSTRY",{"name":158,"class":156},"GlaxoSmithKline",{"name":160,"class":161},"Lungenliga Schweiz","UNKNOWN",{"name":163,"class":156},"Novartis","100361292",false,"NCT03984253","Swiss Severe Asthma Register","Inclusion Criteria:\n\n* In- and outpatients\n* Age ≥ 0 year\n* Informed consent as documented by signature\n\nAdults:\n\n\"Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:\n\n* High level therapy:\n\n  1. high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier\u002Ftheophylline) for the previous year or\n  2. Daily long-term therapy with systemic corticosteroids (CS) for ≥50% of the previous year to prevent it from becoming \"uncontrolled\" or which remains \"uncontrolled\" despite this therapy or\n  3. Therapy with monoclonal antibodies independent from the co-therapy\n* Middle level therapy:\n\nProtokollsynopsis SAR Version 01 16.01.2019 Seite 4\u002F10 a) Daily long-term therapy with medium-to high-dose ICS (≥500 μg Beclomethason (powder) or equivalent in combination with LABA or leukotriene modifier\u002Ftheophylline) for the previous year and uncontrolled asthma defined as at least one of the following:\n\n* Poor symptom control: ACQ consistently \\>1.5, ACT \\\u003C20 (or \"not well controlled\" by NAEPP\u002FGINA guidelines).\n* Frequent severe exacerbations: two or more bursts of systemic CS (\\>3 days each) in the previous year.\n* Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year.\n* Airflow limitation: after appropriate bronchodilator withhold FEV1 \\\u003C80% predicted (in the face of reduced FEV1\u002FFVC defined as less than the lower limit of normal).\n* Controlled asthma that worsens on tapering of these high doses of ICS or systemic CS (or additional biologics). The presence of any one of the following exclusion criteria will lead to exclusion of the patients:\n* Life-expectancy \\\u003C6 months\n* Insufficient knowledge of project language\n\nChildren:\n\nThe criteria for severe or difficult asthma in children and adolescents are considered fulfilled in the case of insufficient symptom control in the last year despite medium\u002Fhigh antiinflammatory long-term therapy:\n\n* age 0-18 years, at time of inclusion\n* diagnosis of bronchial asthma made by a physician\n* differential diagnoses excluded\n* good compliance and trained inhalation technique\n* treatment with biological approved for the treatment of severe asthma (currently only omalizumab) or\n\nProof of:\n\na) Positive Bronchodilation-test (≥12% increase in FEV1 after SABA) or b) Significant bronchial hyperresponsiveness after nonspecific provocation (e.g., with Methacholine or treadmill) according to ATS criteria (AJRCCM 2000)\n\n* High level of therapy:\n\n  1. Prolonged therapy with high dose inhaled steroid (ICS) (\\> 400 μg Budesonide equivalent \u002F\\> 200 μg fluticasone alone); or\n  2. Daily long-term therapy with medium- to high-dose ICS (≥ 400 μg Budesonide equivalent \u002F ≥200 μg fluticasone) in combination with long-acting betaagonists and \u002F or leukotriene receptor antagonist and \u002F or theophylline; or\n  3. Therapy with oral steroids fixed ≥3 last months.\n* Insufficient asthma control\n\n  a) Inadequate symptom control after NVL in the last 4 weeks: Protokollsynopsis SAR Version 01 16.01.2019 Seite 5\u002F10\n  * ≥3 x weekly asthma symptoms or use of ondemand medication; Or:\n  * limited activity due to asthma; Or:\n  * any symptoms at night; or b. Exacerbation(s) ≥1 last year that required treatment with systemic steroids and \u002F or inpatient treatment c. limited lung function:\n  * pathological Tiffeneau quotient or FEV1 at inclusion.\n* Submission of a written consent (parent\u002F legal guardian).\n\nExclusion Criteria:\n\n* Life-expectancy \\\u003C6 months · Insufficient knowledge of project language","ALL","1 Year",{"count":172,"type":173},600,"ESTIMATED","15 Years","OBSERVATIONAL","Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity.\n\nDespite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma.\n\nBased on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death.\n\nSeveral severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods.\n\nApproximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated.\n\nFor all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.",[9],[179,180,181],"Asthma","Severe","Register","2025-03-10",{"date":184,"type":185},"2025-03-12","ACTUAL",{"date":187,"type":185},"2019-05-13",{"date":189,"type":173},"2034-02-28",{"name":151,"class":6},10]