Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee Graduate School of Medicine
Study ID
NCT04655170
Phase
PHASE4
Status
Recruiting
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Conditions

  • COPD Exacerbation

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revefenacin (YUPELRI) & Formoterol (Perforomist) — DRUG
    Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).
  • Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) — DRUG
    Albuterol Inhalation Aerosol (short-acting beta-agonists) \& Ipratropium Aerosol (short-acting anticholinergic)

Study Details

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.

Key Dates

First listed
Dec 7, 2020
Start date
Dec 9, 2020
Status verified
Nov 2022
Primary completion
Jan 30, 2023
Completion
Mar 30, 2023

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
    Revefenacin 175 μg once per day and Formoterol 20 μg twice per day via jet nebulizer for 7 days or until discharge if prior to day 7.
  • Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care
    Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.

Primary Outcome Measure

Difference in Borg Dyspnea Scale scores between groups [ Time Frame: change from baseline borg dyspnea score at day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee Medical CenterKnoxvilleTennessee37920-6999
Jennifer Ferris, MSHS
[email protected]
865-305-7975

Find similar trials in Knoxville, TN

By research site
University of Tennessee Medical Center· Knoxville, TN

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