[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648511":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":41,"centralContacts":41,"locations":54,"responsibleParty":74,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":41,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":41,"enrollmentInfo":89,"targetDuration":41,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":100,"whyStopped":41,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)","EXPERIMENTAL","Participants will receive Revefenacin 175 µg once daily and Formoterol 20 µg twice daily via a jet nebulizer for up to 7 days or until hospital discharge (if discharge occurs before Day 7). Participants will also receive placebo (sterile normal saline) to maintain blinding and mask the difference in dosing frequency compared with the comparator arm.",[13,14,15],"Drug: Revefenacin","Drug: formoterol fumarate","Other: Placebo (Sterile Normal Saline)",{"label":17,"type":18,"description":19,"interventionNames":20},"Group2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin)","ACTIVE_COMPARATOR","Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.",[21,22],"Drug: Albuterol sulfate","Drug: Ipratropium Bromide",[24,31,37,42,48],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Revefenacin","Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.",[9],[30],"YUPELRI",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"formoterol fumarate","Formoterol fumarate 20 μg in 2 mL inhalation solution administered twice daily in the morning and evening via oral inhalation using a jet nebulizer.",[9],[36],"Perforomist",{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Placebo (Sterile Normal Saline)","Twice daily (sterile normal saline 3 ml) to maintain blinding and mask the difference in dosing frequency compared with the comparator arm.",[9],null,{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Albuterol sulfate","Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.",[17],[47],"Ventolin",{"type":25,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Ipratropium Bromide","Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.",[17],[53],"Atrovent",[55],{"facility":56,"status":41,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of Tennessee Medical Center","Knoxville","Tennessee","37920","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-83.92074,35.96064,{"lat":66,"lon":65},[69],{"name":70,"role":71,"phone":72,"phoneExt":41,"email":73},"Jennifer Ferris, MSHS","CONTACT","865-305-7975","jferris@utmck.edu",{"type":75,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[77],{"name":78,"class":79},"Viatris Inc.","INDUSTRY","100648511","phase-4-efficacy-of-nebulized-long-acting-bronchodilators-formoterol-and-revefenacin-vs-short-acting-bronchodilators-albuterol-and-ipratropium-in-patients-presenting-to-the-emergency-department-with-acute-exacerbation-of-copd-ecopd-100648511",false,"NCT07721922","Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)","Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD): A Phase IV, Prospective, Randomized, Blinded, Parallel-group Trial","Inclusion Criteria:\n\n1. Male or Female\n2. Any Race\n3. ≥ 40 years of age\n4. History of COPD based on EMR or confirmed verbally by the patient\n5. Presenting to the ED with a primary diagnosis of ECOPD or acute respiratory failure with a secondary diagnosis of COPD\n6. Able to understand and comply with study procedures\n7. Willingness to sign and date an Informed Consent Form\n\nExclusion Criteria:\n\n1. Patients unable or unwilling to sign an informed consent or cooperate with study procedures\n2. Patients who are hypersensitive to Formoterol or Revefenacin\n3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway\n4. Patients who have previously participated in the study\n5. Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support based on:\n\n   i. Inability to maintain respiratory effort ii. Cyanosis iii. Hemodynamic instability iv. Deterioration in mental status\n6. Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, recent MI (within 12 weeks), ventricular arrhythmia, or decompensated heart failure)\n7. Patients with a current diagnosis of lung cancer requiring treatment\n8. Pulmonary diseases other than COPD, or lobar pneumonia\n9. Patients with acute psychiatric illness deemed significant by the investigator\n10. Patients with a history of glaucoma deemed significant by the investigator\n11. History of urinary retention deemed significant by the investigator\n12. Women who are pregnant or breastfeeding","ALL","40 Years",{"count":90,"type":91},280,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","The primary aim is to determine whether nebulized Formoterol twice daily plus Revefenacin once daily is non-inferior to standard-of-care nebulized Albuterol and Ipratropium therapy four times daily in relieving dyspnea among patients with ECOPD presenting to the ED and requiring hospitalization, as measured by the Modified Borg Dyspnea Scale.\n\nThe hypothesize is that patients in the ED for ECOPD, improvement in symptoms, safety, and length of ED or hospital stay after treatment with nebulized Revefenacin and Formoterol will be non-inferior to the Albuterol and Ipratropium combination. The long-acting bronchodilator regimen will provide comparable symptom control with fewer total drug doses compared with standard treatment with short-acting bronchodilators, namely, nebulized Albuterol and Ipratropium. To the best of our knowledge, this will be the first prospective, randomized, double-blind investigation to compare a combination of long-acting nebulized LAMA\u002FLABA bronchodilators with a standard-of-care combination of short-acting nebulized SAMA\u002FSABA bronchodilators in patients with an ECOPD in the ED\u002Fhospital setting.",[97],"COPD Exacerbation",[99],"ECOPD","NOT_YET_RECRUITING","2026-08-14",{"date":103,"type":104},"2026-08-17","ACTUAL",{"date":106,"type":91},"2026-09-01",{"date":108,"type":91},"2028-09-01",{"name":5,"class":6},1]