[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603235":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":46,"centralContacts":46,"locations":47,"responsibleParty":78,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":46,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":46,"enrollmentInfo":93,"targetDuration":46,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":50,"whyStopped":46,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"DPI Treatment Group","ACTIVE_COMPARATOR","Group A: Receives Umeclidinium 62.5 µg and Vilanterol 25 µg via DPI and Revefenacin placebo and formoterol placebo (sterile normal saline) via nebulizer at treatment visit # 2 and will continue with assigned treatment and placebo for 12 weeks",[13,14],"Drug: umeclidinium 62.5 µg and vilanterol 25 µg","Drug: Placebo ( Revefenacin and Formoterol )",{"label":16,"type":10,"description":17,"interventionNames":18},"Nebulizer Treatment Group","Group B: Receives revefenacin 175 µg and formoterol 20 µg via nebulizer and placebo DPI at treatment visit # 2 and will continue with assigned treatment and placebo for 12 weeks",[19,20],"Drug: Revefenacin 175 µg, Formoterol 20 µg","Drug: Placebo DPI",[22,29,36,42],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","umeclidinium 62.5 µg and vilanterol 25 µg","DPI Treatment",[9],[28],"Anoro Ellipta",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Revefenacin 175 µg, Formoterol 20 µg","Nebulizer Treatment",[16],[34,35],"Yupelri","Perforomist",{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo ( Revefenacin and Formoterol )","Placebo Nebulizer Treatment",[9],[41],"Normal Saline",{"type":23,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Placebo DPI","Placebo DPI Treatment",[16],null,[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"The University of Tennessee Graduate School of Medicine","RECRUITING","Knoxville","Tennessee","37920","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-83.92074,35.96064,{"lat":60,"lon":59},[63,68,71,74,76],{"name":64,"role":65,"phone":66,"phoneExt":46,"email":67},"Tracy Walker, Study Coordinator","CONTACT","865-305-4297","twalker5@utmck.edu",{"name":69,"role":70,"phone":46,"phoneExt":46,"email":46},"Rajiv Dhand, MD","PRINCIPAL_INVESTIGATOR",{"name":72,"role":73,"phone":46,"phoneExt":46,"email":46},"Isaac Biney, MD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":46,"phoneExt":46,"email":46},"Samuel Treat, MD",{"name":77,"role":73,"phone":46,"phoneExt":46,"email":46},"Paul Terry, PhD",{"type":79,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[81],{"name":82,"class":83},"Theravance Biopharma","INDUSTRY","100603235","phase-4-compare-the-effects-of-nebulizer-versus-inhaler-based-therapy-for-copd-using-long-acting-bronchodilators-100603235",false,"NCT07133880","Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators","Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Age \\> 40 years\n2. Either sex\n3. Current smoker or past cigarette smoking history of \\> 10 pack-years\n4. Symptoms of COPD (cough, sputum production, shortness of breath)\n5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening\u002FRun-in visit\n6. A PIFR \\> 30 at screening\n7. FEV1\u002FFVC ratio \\\u003C 70% (within the past 12 months)\n8. Residual volume (RV) ≥ 120% predicted (within the past 12 months\n\nExclusion Criteria:\n\n1. Diagnosis of asthma (Verification via medical record and\u002For patient report)\n2. Previously diagnosed atrial fibrillation with rapid ventricular response (heart rate \\> 110 bpm) or ventricular arrhythmia (ventricular tachycardia) (Verification via medical record and\u002For patient report)\n3. Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and\u002For patient report)\n4. Acute exacerbation of congestive heart failure (Verification via medical record and\u002For patient report)\n5. Acute exacerbation of COPD within 8 weeks (Verification via medical record and\u002For patient report)\n6. Recent (within 8 weeks) h\u002Fo eye surgery (Verification via medical record and\u002For patient report)\n7. Uncontrolled glaucoma (Verification via medical record and\u002For patient report)\n8. Known diagnosis of liver cirrhosis (Verification via medical record and\u002For patient report)\n9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \\> 2.5 mg\u002FdL - Verification via medical record and\u002For patient report)\n10. Intolerance to any of the study drugs\n11. Patients receiving long-term azithromycin\n12. Planned surgery requiring hospital admission within 3 months\n13. Currently enrolled in a pulmonary rehabilitation program\n14. Inability to give informed consent\n15. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants)\n16. Inability to understand instructions or comply with the study protocol\n17. Participation in another investigational drug clinical trial within 30 days of patient study registration\n\nMedical history can be confirmed by medical records and\u002For verbal confirmation from patients. However, Inclusion criteria 6 \\& 7 must be verified by a previous PFT report dated within 6 months of screening","ALL","40 Years",{"count":94,"type":95},72,"ESTIMATED","INTERVENTIONAL",[98],"PHASE4","The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1\u002FFVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted).\n\nThe investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent\u002Flong-acting beta agonist (LAMA\u002FLABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA\u002FLABA therapy given by a DPI.\n\nThe study aims to demonstrate the following:\n\n1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA\u002FLABA by DPI with those receiving LAMA\u002FLABA by nebulizer\n2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline\u002FTransition Dyspnea Index (BDI\u002FTDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA\u002FLABA by DPI with those receiving LAMA\u002FLABA by nebulizer",[101],"COPD (Chronic Obstructive Pulmonary Disease)",[103,104,105,106],"Chronic Obstructive Pulmonary Disease","COPD","Nebulizer","Dry Powder Inhaler","2025-08-20",{"date":109,"type":110},"2025-08-27","ACTUAL",{"date":112,"type":110},"2023-12-05",{"date":114,"type":95},"2025-12-01",{"name":5,"class":6},1]