Long-Acting vs Short-Acting Bronchodilators for COPD

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Tennessee Graduate School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new combination of long-acting inhaled medications can help people with COPD (a lung disease that causes breathing problems) as effectively as the current standard treatment. The trial will assess whether taking Formoterol and Revefenacin, both long-acting bronchodilators, fewer times a day is as effective as taking Albuterol and Ipratropium, short-acting bronchodilators, more frequently. It will focus on symptom relief, safety, and the length of hospital stay for individuals experiencing a flare-up of COPD symptoms. Those diagnosed with COPD and currently experiencing a flare-up requiring hospital care might be suitable for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

What is the safety track record for these treatments?

Research has shown that combining Revefenacin and Formoterol is generally safe for people with COPD. Common side effects include worsening COPD symptoms, cough, and dizziness. Importantly, no reports of serious side effects or deaths have been linked to this treatment, indicating its safety.

Revefenacin and Formoterol have undergone thorough study, and the FDA has already approved Revefenacin for treating COPD. This approval adds confidence in its safety when used with Formoterol. Overall, evidence suggests these medications are safe options with manageable side effects for people with COPD.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for COPD because they explore different approaches to managing symptoms. Revefenacin and Formoterol are unique because they combine a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA), offering the potential for sustained relief with less frequent dosing. Unlike the standard short-acting options like Albuterol and Ipratropium, which require more frequent administration, this combination could improve patient compliance and convenience. Additionally, the use of nebulized delivery ensures that patients with severe symptoms receive consistent dosing, which is crucial for effective management of COPD.

What evidence suggests that this trial's treatments could be effective for COPD?

Studies have shown that Revefenacin and Formoterol, which participants in this trial may receive, effectively treat COPD, a lung disease that makes breathing difficult. Specifically, Revefenacin significantly improves lung function and reduces COPD flare-ups by 15% to 18% compared to a placebo. It also enhances quality of life, particularly for women with COPD. Formoterol provides long-lasting relief from breathing problems. Together, these medications aim to offer lasting relief with fewer doses than short-acting treatments like Albuterol and Ipratropium, tested in another arm of this trial.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 40 or older who come to the emergency department with a COPD flare-up and need hospitalization. Participants must have a history of COPD, be able to give consent, and not have certain other lung diseases, severe heart problems, significant urinary retention or glaucoma, or be pregnant.

Inclusion Criteria

I am at least 40 years old.
I can understand and follow the study instructions.
Willingness to sign and date an Informed Consent Form
See 4 more

Exclusion Criteria

Patients who have previously participated in the study
I currently have lung cancer that needs treatment.
I have had significant problems with urinary retention.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either nebulized Formoterol and Revefenacin or Albuterol and Ipratropium for up to 7 days or until hospital discharge

7 days
Daily monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Albuterol sulfate
  • Formoterol fumarate
  • Ipratropium Bromide
  • Revefenacin

Trial Overview

The study compares two inhaled treatments for sudden COPD worsening: one group gets long-acting bronchodilators (Formoterol twice daily plus Revefenacin once daily), while the other receives standard short-acting bronchodilators (Albuterol and Ipratropium four times daily). Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)Experimental Treatment3 Interventions
Group II: Group2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials
17
Recruited
1,400+

Viatris Inc.

Industry Sponsor

Trials
11
Recruited
5,600+

Citations

Viatris and Theravance Biopharma Announce ...

Top-line results from Phase III study in China demonstrate the efficacy and safety profile of YUPELRI in patients with COPD. YUPELRI met its primary efficacy ...

FDA Approves Once-Daily Nebulized Therapy for ...

revefenacin reduced rates of COPD exacerbations from 15% to 18% in moderate-to-very-severe COPD for up to 52 weeks when compared with placebo ...

YUPELRI® (revefenacin) inhalation solution

More than 28 million doses pack-years moderate to very severe COPD. Consistent improvements in trough FEV1 over the 12-week study period1,3 YUPELRI met its ...

COPD Patient-Reported Outcomes With Revefenacin

Revefenacin showed significant improvement in trough FEV1 at Day 85 compared with placebo independent of anxiety and depression status (similar results were ...

Nebulized Revefenacin for COPD Appears More Effective ...

Research presented at CHEST 2021 shows revefenacin significantly improved QoL in women with COPD, who tend to have more severe disease than ...

Safety and Efficacy of Revefenacin and Formoterol in ... - PMC

The most common AEs were worsening/exacerbation of COPD, cough, and dizziness. There were no serious AEs or deaths reported in any arm. The least squares mean ...

Safety, Efficacy, and Feasibility of Nebulized Long-Acting ...

In hospitalized patients with exacerbations of COPD, is a combination of nebulized long-acting formoterol/revefenacin as safe and effective as ...

Revefenacin, a once-daily, long-acting muscarinic antagonist ...

Revefenacin treatment delivered via nebulization led to improvements in lung function in patients with COPD. It was also generally well tolerated, with no major ...

Efficacy Data | YUPELRI® (revefenacin) inhalation solution

Delivers a full 24 hours of lung function improvement in a single nebulized daily dose · Delivers consistent control † over 12 weeks for better breathing and ...

Theravance Biopharma and Mylan to Present New Data on ...

Study provides data on YUPELRI when administered with formoterol in patients with COPD. Additional data characterizes baseline demographics ...