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Long-Acting Bronchodilator
Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
Phase 4
Waitlist Available
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from day 3 borg dyspnea score at day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from day 3 borg dyspnea score at day 7
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 moreAwards & 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
165 Previous Clinical Trials
12,900 Total Patients Enrolled
University of Tennessee Graduate School of MedicineLead Sponsor
14 Previous Clinical Trials
1,306 Total Patients Enrolled