NCT04655170

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Tennessee Graduate School of Medicine · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, parallel group, randomized clinical trial in 60 patients hospitalized with the primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD (ICD-10 codes J44.1 and J96 - J96.2 with J44.9). The plan is to: Administer standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours (n=30) versus Nebulized Revefenacin 175 μg once per day and Formoterol 20 μg twice per day (n=30) for up to 7 days of treatment. Study medication will be administered by standard jet nebulizers in both groups. Investigators will: * Collect the Borg dyspnea scale twice a day during hospitalization * Record the total doses of bronchodilators per day received by each patient * Record the number of rescue doses needed per day of hospital stay * Record the lowest level of FiO2 employed on days 1, 3 and 7 of hospital stay * Record all adverse events and concurrent medications Investigators will collect: Physical Exam (Day 1, 3, 7, or ET) Serum Chemistry (Day 1, 3, 7, or ET) Hematology (Day 1, 3, 7, or ET) Chest X-Ray (Day 1).

Conditions

• COPD Exacerbation

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-12-09
• Primary completion: 2023-01-30
• Completion: 2023-03-30
• First posted: 2020-12-07
• Last updated: 2022-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study