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Long-Acting Bronchodilator

Revefenacin (YUPELRI) & Formoterol (Perforomist) for Chronic Obstructive Pulmonary Disease

Phase 4
Recruiting
Research Sponsored by University of Tennessee Graduate School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from day 3 borg dyspnea score at day 7
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new treatment involving inhaled Formoterol and Revefenacin for patients hospitalized with severe COPD. These medications work together to relax and open up the airways, making it easier to breathe. The goal is to see if this new combination is safer and more effective than the current options. Formoterol is a long-acting beta2-agonist that has been widely studied for its efficacy in treating COPD, while Revefenacin is a long-acting muscarinic antagonist designed for nebulized therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from day 3 borg dyspnea score at day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from day 3 borg dyspnea score at day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Borg Dyspnea Scale scores between groups
Bronchodilator Agents
Therapeutic procedure
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)Experimental Treatment1 Intervention
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 II: Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of CareActive Control1 Intervention
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.

Find a Location

Who is running the clinical trial?

Mylan Pharmaceuticals IncIndustry Sponsor
163 Previous Clinical Trials
11,232 Total Patients Enrolled
University of Tennessee Graduate School of MedicineLead Sponsor
13 Previous Clinical Trials
1,099 Total Patients Enrolled
~12 spots leftby Nov 2025
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