[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07721922":3,"trial-entities:NCT07721922":116,"trial-summary:NCT07721922":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":60,"secondary_outcomes":65,"sex":86,"minimum_age":87,"maximum_age":15,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":93,"locations":96,"central_contacts":112,"overall_officials":113,"references":114,"see_also_links":115},"NCT07721922","5482","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","NOT_YET_RECRUITING","2028-09-01","2026-06","2026-07-23","2026-09-01","University of Tennessee Graduate School of Medicine","OTHER",null,"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.",[18],"COPD Exacerbation",[20],"ECOPD","INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},280,"ESTIMATED",[29,37,43,47,54],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Revefenacin","Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.",[34],"Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)",[36],"YUPELRI",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"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.",[34],[42],"Perforomist",{"type":14,"name":44,"description":45,"armGroupLabels":46},"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.",[34],{"type":30,"name":48,"description":49,"armGroupLabels":50,"otherNames":52},"Albuterol sulfate","Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.",[51],"Group2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin)",[53],"Ventolin",{"type":30,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Ipratropium Bromide","Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.",[51],[59],"Atrovent",[61],{"measure":62,"description":63,"timeFrame":64},"Difference in Modified Borg Dyspnea Scale scores between groups","This is a scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This will be recorded prior to dosing twice a day between 7 and 9 am \\& pm. Scores from Group 1 and Group 2 will be averaged and compared.","From enrollment through Day 7 (end of treatment)",[66,68,70,72,74,76,78,81,83],{"measure":67,"timeFrame":64},"Number of patients discharged home from the ED",{"measure":69,"timeFrame":64},"Number of patients admitted to a hospital floor or require ED observation for >24 hours (in-hospital patients)",{"measure":71,"timeFrame":64},"Length of hospital or ED stay",{"measure":73,"timeFrame":64},"Number of Participants with the Need to Switch Therapy",{"measure":75,"timeFrame":64},"Total number of bronchodilator doses per hospital or ED stay",{"measure":77,"timeFrame":64},"Total number of rescue doses used",{"measure":79,"description":80,"timeFrame":64},"Number of Participants with Failure of Treatment (Need for Mechanical Ventilation or Death","Failure of treatment will be defined as any of the following: death, the need for a patient to receive mechanical ventilation, or the need for a patient to discontinue long-acting bronchodilators during the trial. The need for rescue medications while maintaining the assigned treatment will not be considered a failure of treatment.",{"measure":82,"timeFrame":64},"Number of Participants Requiring Supplemental Oxygen",{"measure":84,"description":85,"timeFrame":64},"Differences in FEV1\u002FFVC values between enrollment and discharge\u002Fend of study.","Bedside spirometry will be performed by respiratory therapists with the patient in a sitting position using a handheld portable spirometer. The patient will be asked to make a tight seal around the mouthpiece with their lips and forcefully exhale after a deep inhalation. The patient will be instructed to continue forceful and rapid exhalation until no more air is expelled from their lungs. The best of 3 efforts will be used for analysis. FEV1\u002FFVC\\\u003C0.7 will be used to diagnose airflow obstruction.","ALL","40 Years",false,{"inclusion":90,"exclusion":91,"raw_text":92},[],[],"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",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":109},"University of Tennessee Medical Center","Knoxville","Tennessee","37920","United States",[104],{"name":105,"role":106,"phone":107,"email":108},"Jennifer Ferris, MSHS","CONTACT","865-305-7975","jferris@utmck.edu",{"lat":110,"lon":111},35.96064,-83.92074,[],[],[],[],{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Chronic Obstructive Pulmonary Disease",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study planning to enroll 280 participants. It compares different nebulized medications for COPD exacerbations.","completed","Nebulized Bronchodilators for COPD Exacerbations","This study is looking at how well two nebulized medications, Revefenacin and Formoterol, work for people who come to the emergency department (ED) with a sudden worsening of their COPD (ECOPD). These are long-acting bronchodilators, meaning they help open your airways for a longer time. The study compares them to the usual treatment, which is nebulized Albuterol and Ipratropium, which are short-acting bronchodilators. Researchers want to see if the new combination is just as good at easing your breathing difficulties, measured by the Modified Borg Dyspnea Scale. You can join if you are at least 40 years old, have a history of COPD, and are in the ED for an ECOPD.","Your breathing difficulties will be monitored from when you join the study through Day 7 (the end of treatment).",111,"Participants will receive study medications via nebulizer daily for up to 7 days. Your breathing difficulties will be measured during this time.","Not stated in the trial record.",[31],"v2"]