[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598627":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":107,"collaborators":109,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":26,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1: BGF MDI and Placebo","EXPERIMENTAL","Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.",[13,14,15],"Drug: Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate","Drug: Placebo","Device: Metered dose inhaler",{"label":17,"type":10,"description":18,"interventionNames":19},"Sequence 2: Placebo and BGF MDI","Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate","BGF will be administered as 2 inhalations via oral route of administration",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo will be administered as 2 inhalations via oral route of administration",[9,17],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DEVICE","Metered dose inhaler","Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.",[9,17],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[43,56,64,72,80,91,99],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"Research Site","RECRUITING","Ahrensburg","22926","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],10.23705,53.67661,{"lat":54,"lon":53},{"facility":44,"status":45,"city":57,"state":26,"zip":58,"country":48,"countryCode":49,"cosmosGeoPoint":59,"geoPoint":63,"contacts":26},"Berlin","14050",{"type":51,"coordinates":60},[61,62],13.41053,52.52437,{"lat":62,"lon":61},{"facility":44,"status":45,"city":65,"state":26,"zip":66,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":71,"contacts":26},"Frankfurt","60596",{"type":51,"coordinates":68},[69,70],10.53333,49.68333,{"lat":70,"lon":69},{"facility":44,"status":45,"city":73,"state":26,"zip":74,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":26},"Hanover","30625",{"type":51,"coordinates":76},[77,78],9.73322,52.37052,{"lat":78,"lon":77},{"facility":44,"status":81,"city":82,"state":26,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":26},"WITHDRAWN","Harefield","UB9 6JH","United Kingdom","UK",{"type":51,"coordinates":87},[88,89],-0.48546,51.60333,{"lat":89,"lon":88},{"facility":44,"status":45,"city":92,"state":26,"zip":93,"country":84,"countryCode":85,"cosmosGeoPoint":94,"geoPoint":98,"contacts":26},"London","W1T 6AH",{"type":51,"coordinates":95},[96,97],-0.12574,51.50853,{"lat":97,"lon":96},{"facility":44,"status":45,"city":100,"state":26,"zip":101,"country":84,"countryCode":85,"cosmosGeoPoint":102,"geoPoint":106,"contacts":26},"Manchester","M23 9QZ",{"type":51,"coordinates":103},[104,105],-2.23743,53.48095,{"lat":105,"lon":104},{"type":108,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[110],{"name":111,"class":6},"Parexel","100598627","phase-4-a-study-to-investigate-the-effect-of-budesonideglycopyrroniumformoterol-fumarate-metered-dose-inhaler-bgf-mdi-compared-with-placebo-mdi-on-heart-and-lung-function-in-participants-with-chronic-obstructive-pulmonary-disease-copd-and-hyperinflation-100598627",false,"NCT07073950","A Study to Investigate the Effect of Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation","A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide\u002FGlycopyrronium\u002FFormoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation","ORATOS","Key Inclusion Criteria:\n\n* Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.\n* A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second\u002Fforced vital capacity (FEV1\u002FFVC) \\\u003C 0.7.\n* At Visit 1: A pre-bronchodilator FEV1 \\\u003C 80%.\n* At Visit 1: Peripheral blood eosinophil count \\\u003C 300 cells\u002Fcubic millimeter (mm³), with no recorded history of eosinophil count \\> 300 cells\u002Fmm³ in the past 12 months.\n* At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.\n* At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \\> 135% of predicted normal FRC.\n* At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of the predicted normal value.\n* Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.\n* Female participants must either be not of childbearing potential or using a form of highly effective birth control.\n* All women of child bearing potential must have a negative pregnancy test at the Visit 1.\n\nExclusion Criteria:\n\n* A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.\n* History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.\n* History of myocardial infarction or acute coronary syndrome.\n* History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).\n* Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.\n* Participants with ECG QTcF interval at Visit 1 \\> 460 milliseconds (ms) for males and \\> 480 ms for females.\n* Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and\u002For during the screening\u002Frun-in period.\n* Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.","ALL","40 Years","80 Years",{"count":124,"type":125},56,"ESTIMATED","INTERVENTIONAL",[128],"PHASE4","The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.",[131,132],"Chronic Obstructive Pulmonary Disease","Hyperinflation",[134,135,136,137],"Metered Dose Inhalers (MDI)","Inhaled Corticosteroid (ICS)","Long-acting muscarinic antagonist (LAMA)","Long-acting beta2 agonist (LABA)","2026-07-01",{"date":140,"type":141},"2026-07-02","ACTUAL",{"date":143,"type":141},"2025-11-24",{"date":145,"type":125},"2027-05-31",{"name":5,"class":6},7]