RightFit
Not yet recruitingPhase 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)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether long-acting breathing medicines (formoterol and revefenacin) ease shortness of breath as well as short-acting medicines (albuterol and ipratropium), with fewer doses. The medicines are breathed in as a mist through a machine called a nebulizer. The study is for adults age 40 or older who come to the emergency room with a flare-up of COPD, a long-term lung disease, and need a hospital stay.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older, of any sex or race.
  • Have COPD, based on medical records or what you tell the study team.
  • Come to the emergency room mainly for a COPD flare-up, or for sudden breathing failure with COPD also diagnosed.
  • Can understand and follow the study steps.
  • Are willing to sign and date a form agreeing to join the study.

Who can't join

  • Cannot or will not sign the consent form or follow study steps, or have already taken part in this study.
  • Are allergic to formoterol or revefenacin.
  • Have a breathing tube or an opening in the neck for breathing, use a breathing machine through a mask or tube, or are getting worse quickly and need or may soon need a breathing machine.
  • Have unstable heart or blood vessel disease, such as uncontrolled high blood pressure, unstable chest pain, a heart attack within 12 weeks, an abnormal rhythm in the heart’s lower chambers, or worsening heart failure.
  • Have lung cancer that needs treatment, a lung disease other than COPD, or pneumonia in one section of the lung.
  • Have a current mental illness that the study doctor considers serious.
  • Have a history of glaucoma (an eye disease) or trouble emptying the bladder that the study doctor considers serious.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TN