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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)

20 luglio 2026 aggiornato da: University of Tennessee Graduate School of Medicine

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

280

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37920
        • University of Tennessee Medical Center
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Male or Female
  2. Any Race
  3. ≥ 40 years of age
  4. History of COPD based on EMR or confirmed verbally by the patient
  5. Presenting to the ED with a primary diagnosis of ECOPD or acute respiratory failure with a secondary diagnosis of COPD
  6. Able to understand and comply with study procedures
  7. Willingness to sign and date an Informed Consent Form

Exclusion Criteria:

  1. Patients unable or unwilling to sign an informed consent or cooperate with study procedures
  2. Patients who are hypersensitive to Formoterol or Revefenacin
  3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
  4. Patients who have previously participated in the study

  5. Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support based on:

    i. Inability to maintain respiratory effort ii. Cyanosis iii. Hemodynamic instability iv. Deterioration in mental status

  6. 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)
  7. Patients with a current diagnosis of lung cancer requiring treatment
  8. Pulmonary diseases other than COPD, or lobar pneumonia
  9. Patients with acute psychiatric illness deemed significant by the investigator
  10. Patients with a history of glaucoma deemed significant by the investigator
  11. History of urinary retention deemed significant by the investigator
  12. Women who are pregnant or breastfeeding

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
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.
Droga: Revefenacin
Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.
Altri nomi:
  • YUPELRI
Droga: 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.
Altri nomi:
  • Perforista
Altro: 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.
Comparatore attivo: Group2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin)
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
Droga: Albuterol sulfate
Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Altri nomi:
  • Ventolin
Droga: Ipratropium Bromide
Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Altri nomi:
  • Atrovent

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in Modified Borg Dyspnea Scale scores between groups
Lasso di tempo: 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.
From enrollment through Day 7 (end of treatment)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of patients discharged home from the ED
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Number of patients admitted to a hospital floor or require ED observation for >24 hours (in-hospital patients)
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Length of hospital or ED stay
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Number of Participants with the Need to Switch Therapy
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Total number of bronchodilator doses per hospital or ED stay
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Total number of rescue doses used
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Number of Participants with Failure of Treatment (Need for Mechanical Ventilation or Death
Lasso di tempo: 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.
From enrollment through Day 7 (end of treatment)
Number of Participants Requiring Supplemental Oxygen
Lasso di tempo: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Differences in FEV1/FVC values between enrollment and discharge/end of study.
Lasso di tempo: 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.
From enrollment through Day 7 (end of treatment)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Tennessee Graduate School of Medicine

Collaboratori

Viatris Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

23 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5482

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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