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

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04655170
• Other study ID #: UTGSM 4586
• Status: Recruiting
• Phase: Phase 4
• Start date: December 9, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2022
• Source: University of Tennessee Graduate School of Medicine
• Contact: Jennifer Ferris, MSHS
• Phone: 865-305-7975
• Email: jferris[@]utmck.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Drug:
• Revefenacin (YUPELRI) & Formoterol (Perforomist)
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)
Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)

Locations

Country	Name	City	State
United States	University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee Graduate School of Medicine	Mylan Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Borg Dyspnea Scale scores between groups	This is a scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This will be recorded prior to dosing twice a day between 7 and 9 am & pm. Scores from Group 1 and Group 2 will be averaged and compared.	change from baseline borg dyspnea score at day 3
Primary	Difference in Borg Dyspnea Scale scores between groups	This is a scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This will be recorded prior to dosing twice a day between 7 and 9 am & pm. Scores from Group 1 and Group 2 will be averaged and compared.	change from baseline borg dyspnea score at day 7
Primary	Difference in Borg Dyspnea Scale scores between groups	This is a scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This will be recorded prior to dosing twice a day between 7 and 9 am & pm. Scores from Group 1 and Group 2 will be averaged and compared.	change from day 3 borg dyspnea score at day 7
Primary	Difference in the mean total doses of short acting bronchodilators (rescue) used during study participation between each group.	Subject in both groups will be allowed to use standard of care rescue short-acting bronchodilators throughout their study participation.	up to 7 days
Primary	The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2	The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.	at baseline
Primary	The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2	The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.	at day 3
Primary	The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2	The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.	at day 7
Primary	Number of total subjects that had to stop treatment early between groups	Total percent of patients that had to switch therapy due to lack of response between each group.	Through study completion, up to 7 days
Primary	The total number of subjects with Adverse Events, SAE's, ET, and Deaths between groups.	Adverse Events, SAE's, ET, and Deaths will be recorder for every subjects in both groups until the end of their study participation.	Through study completion, up to 7 days