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Tests treatment safety and results for COPD Exacerbation
Official title Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
ClinicalTrials.gov ID: NCT04655170
What this study is testing
What is Revefenacin (YUPELRI) & Formoterol (Perforomist)?
Revefenacin (YUPELRI) & Formoterol (Perforomist) is an investigational medicine, given as a twice-daily inhaled treatment, being studied as a potential treatment for copd exacerbation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the feasibility, safety and efficacy of a combination of nebulized Formoterol and Revefenacin among patients hospitalized for AECOPD compared with standard-of-care therapy with nebulized Albuterol and Ipratropium.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Male or Female
- Any Race
- ≥ 40 years of age
- Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
- Able to understand and comply with study procedures
You likely can't join if
- Patients unable or unwilling to sign an informed consent or cooperate with study procedures
- Patients who are hypersensitive to Formoterol or Revefenacin
- Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
- Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
- Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled, hypertension, unstable angina, recent MI (within 12...
- Patients with a current diagnosis of lung cancer requiring treatment
See the full eligibility criteria
- Male or Female
- Any Race
- ≥ 40 years of age
- Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
- Able to understand and comply with study procedures
- Willingness to sign and date an Informed Consent Form
- Patients unable or unwilling to sign an informed consent or cooperate with study procedures
- Patients who are hypersensitive to Formoterol or Revefenacin
- Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
- Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
- 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)
- Patients with a current diagnosis of lung cancer requiring treatment
- Patients that test positive for COVID-19
- Pulmonary diseases other than COPD, or lobar pneumonia
- Patients with acute psychiatric illness deemed significant by the investigator
- Patients with a history of glaucoma deemed significant by the investigator
- History of urinary retention deemed significant by the investigator 12 Women who are pregnant or breast feeding
The study team makes the final eligibility decision.
Where it's taking place
- Knoxville, Tennessee, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Knoxville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.