Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
NCT04655170 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2022-11-15
Summary
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.
Conditions
- COPD Exacerbation
Interventions
- DRUG
-
Revefenacin (YUPELRI) & Formoterol (Perforomist)
Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).
- DRUG
-
Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)
Albuterol Inhalation Aerosol (short-acting beta-agonists) \& Ipratropium Aerosol (short-acting anticholinergic)
Sponsors & Collaborators
-
Mylan Pharmaceuticals Inc
collaborator INDUSTRY -
University of Tennessee Graduate School of Medicine
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-09
- Primary Completion
- 2023-01-30
- Completion
- 2023-03-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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