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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. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

280

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • University of Tennessee Medical Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Revefenacin
Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.
Andre navne:
  • YUPELRI
Medicin: 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.
Andre navne:
  • Perforomist
Andet: 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.
Aktiv komparator: 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.
Medicin: Albuterol sulfate
Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Andre navne:
  • Ventolin
Medicin: Ipratropium Bromide
Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Andre navne:
  • Atrovent

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in Modified Borg Dyspnea Scale scores between groups
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients discharged home from the ED
Tidsramme: 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)
Tidsramme: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Length of hospital or ED stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrollment through Day 7 (end of treatment)
From enrollment through Day 7 (end of treatment)
Total number of rescue doses used
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Tennessee Graduate School of Medicine

Samarbejdspartnere

Viatris Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5482

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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