University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
NCT Number: NCT07721922
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.
The 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/LABA bronchodilators with a standard-of-care combination of short-acting nebulized SAMA/SABA bronchodilators in patients with an ECOPD in the ED/hospital setting.
Trial opening soon.
Get Notified40 year and older
All sexes
Interventional
Phase 4
Knoxville, Tennessee, 37920, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
i. Inability to maintain respiratory effort ii. Cyanosis iii. Hemodynamic instability iv. Deterioration in mental status
Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.
Other names: YUPELRI
Formoterol fumarate 20 μg in 2 mL inhalation solution administered twice daily in the morning and evening via oral inhalation using a jet nebulizer.
Other names: Perforomist
Twice daily (sterile normal saline 3 ml) to maintain blinding and mask the difference in dosing frequency compared with the comparator arm.
Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Other names: Ventolin
Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Other names: Atrovent
Time frame: From enrollment through Day 7 (end of treatment)
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.
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
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.
Time frame: From enrollment through Day 7 (end of treatment)
Time frame: From enrollment through Day 7 (end of treatment)
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/FVC<0.7 will be used to diagnose airflow obstruction.
University of Tennessee Graduate School of Medicine
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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