[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380794":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":36,"responsibleParty":52,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Milan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Doxofylline+inhalation therapy","EXPERIMENTAL","4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy, followed by 4-week treatment of maximal inhalation therapy only",[13],"Drug: Doxofylline",{"label":15,"type":10,"description":16,"interventionNames":17},"Inhalation therapy","4-week treatment with maximal inhalation therapy only, followed by 4-week treatment with doxofylline tablets 400 mg bid in addition to maximal inhalation therapy",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Doxofylline","Patients will receive a 4-week treatment with doxofylline 400 mg bid, in addition to their chronic usual inhalation therapy.",[9,15],[25],"Ansimar",null,[28,33],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Pierachille Santus, MD, PhD","CONTACT","0239043801","pierachille.santus@unimi.it",{"name":34,"role":30,"phone":26,"phoneExt":26,"email":35},"Dejan Radovanovic, MD","dejan.radovanovic@unimi.it",[37],{"facility":38,"status":26,"city":39,"state":26,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"L. Sacco Hospital","Milan","20157","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],9.18951,45.46427,{"lat":47,"lon":46},[50],{"name":29,"role":30,"phone":51,"phoneExt":26,"email":32},"0239042801",{"type":53,"investigatorFullName":29,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Professor of Respiratory Diseases, Head of the Respiratory Disease Unit, L. Sacco University Hospital, Milan, Italy","100380794","phase-4-effect-of-add-on-doxofylline-on-lung-function-in-stable-copd-100380794",false,"NCT04238221","Effect of add-on Doxofylline on Lung Function in Stable COPD","Effect of Doxofylline on Bronchial Obstruction, in add-on to Maximal Inhalation Therapy, in Clinically Stable COPD Patients.","EDAI","Inclusion Criteria:\n\n* COPD diagnosis for at least 6 months, according to current European Respiratory Society guidelines\n* baseline FEV1 ≤ 80% of predicted value\n* active or former smokers with smoking history ≥ 10 pack-years\n* patients chronically treated with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonists (LABA), in association with or without an inhaled corticosteroid (ICS)\n* clinically stable disease for 6 months.\n\nExclusion Criteria:\n\n* previous or current diagnosis of bronchial asthma\n* previous lung volume reduction through surgery or endobronchial valves\n* inability to perform respiratory function tests according to international standards, or contraindications to perform 6-minute walking test\n* known allergy or intolerance to doxofylline\n* current or potential pregnancy\n* mini-Mental test \\\u003C21\n* congestive heart failure NYHA III or IV\n* recent (\\\u003C6 months) myocardial infarction\n* unstable arrhythmias\n* chronic hypotension\n* active peptic ulcer\n* severe liver disease\n* active neoplasia\n* history of drug or alcohol abuse.","ALL","40 Years",{"count":66,"type":67},78,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","It is a phase IV, prospective, interventional, single blind, randomized, crossover trial in which the investigators will evaluate the effects of a 4-week treatment with doxofylline 400 mg bid, in add-on to maximal inhalation therapy, in clinically stable COPD patients.",[73],"Chronic Obstructive Pulmonary Disease",[75,76,77,21,78,79,80],"COPD","Bronchodilator","Pulmonary Function Test","Methylxanthines","6-minute walk test","FEV1","NOT_YET_RECRUITING","2026-04-28",{"date":84,"type":85},"2026-04-29","ACTUAL",{"date":87,"type":67},"2026-12-01",{"date":89,"type":67},"2027-12-30",{"name":5,"class":6},1]