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

NCT ID: NCT04655170

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2023-03-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Revefenacin (YUPELRI) & Formoterol (Perforomist)

Intervention Type: DRUG

Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).

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.

Group Type: ACTIVE_COMPARATOR

Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)

Intervention Type: DRUG

Albuterol Inhalation Aerosol (short-acting beta-agonists) \& Ipratropium Aerosol (short-acting anticholinergic)

Interventions

Revefenacin (YUPELRI) & Formoterol (Perforomist)

Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or Female

2. Any Race

3. ≥ 40 years of age

4. Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD

5. Able to understand and comply with study procedures

6. 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, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support

5. 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)

6. Patients with a current diagnosis of lung cancer requiring treatment

7. Patients that test positive for COVID-19

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 breast feeding

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role: collaborator

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Dhand, MD

Professor and Chair Department of Medicine; Division of Pulmonary Medicine Section of Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Ferris, MSHS

Role: CONTACT

jferris@utmck.edu

865-305-7975

Facility Contacts

Jennifer Ferris, MSHS

Role: primary

jferris@utmck.edu

865-305-7975

Other Identifiers

UTGSM 4586

Identifier Type: -

Identifier Source: org_study_id