Nebulizer vs Inhaler for COPD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Tennessee Graduate School of Medicine

Must be taking: LAMA/LABA

Must not be taking: Azithromycin

Disqualifiers: Asthma, Atrial fibrillation, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which treatment method better manages Chronic Obstructive Pulmonary Disease (COPD): a nebulizer or a dry powder inhaler (DPI). Researchers aim to determine if people with COPD experience more relief from symptoms like shortness of breath and coughing when using a nebulizer. Participants will receive a combination of medications, including Formoterol, Revefenacin, Umeclidinium, and Vilanterol (all of which help open airways), administered either by nebulizer or DPI, to measure improvements in lung function and quality of life. Suitable candidates have symptoms of COPD, such as frequent coughing or shortness of breath, and a history of smoking. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, offering participants a chance to contribute to broader knowledge.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on long-term azithromycin, you may not be eligible to participate.

What is the safety track record for these treatments?

Previous studies have shown that both treatment options in this trial are well-tolerated by patients with COPD. For the nebulizer group, research indicates that the combination of revefenacin and formoterol is safe and effective. The FDA has approved revefenacin for use with a nebulizer for COPD, and it does not increase the risk of heart problems, which is reassuring for heart health.

The DPI treatment group, using umeclidinium and vilanterol, also has a strong safety record. Studies have shown that this combination is well-tolerated and significantly improves lung function. Clinical trials suggest that using this DPI once a day is safe and often works as well as or better than other treatments.

Overall, studies have found both treatment options to be safe and effective for people with COPD. This should provide some peace of mind for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these COPD treatments because they explore different delivery methods to improve patient outcomes. Unlike the standard inhaler treatments, the nebulizer treatment uses a combination of formoterol and revefenacin, which could offer enhanced lung delivery and extended relief through the nebulization process. Meanwhile, the DPI (Dry Powder Inhaler) treatment combines umeclidinium and vilanterol, potentially allowing for a more rapid onset of action. By comparing these delivery methods, researchers hope to find out which approach offers better symptom control and convenience for COPD patients.

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

This trial will compare nebulized and dry powder inhaler (DPI) treatments for COPD. Participants in the Nebulizer Treatment Group will receive revefenacin and formoterol via nebulizer. Research shows this combination can significantly improve lung function and reduce symptoms in COPD patients by keeping the airways open, easing breathing, and reducing flare-ups. Meanwhile, participants in the DPI Treatment Group will receive umeclidinium and vilanterol via DPI. Studies indicate this combination also effectively improves lung function and is well-tolerated. Both treatments have shown positive results, but their effectiveness can vary based on individual patient needs and preferences. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people with COPD who have trouble breathing due to narrowed airways and trapped air in the lungs. Participants should show specific levels of airflow obstruction and air trapping. The study excludes individuals not meeting these lung function criteria or those unable to follow the trial procedures.

Inclusion Criteria

A PIFR > 30 at screening

I often feel short of breath.

I am over 40 years old.

Exclusion Criteria

Intolerance to any of the study drugs

I am on long-term azithromycin treatment.

I had eye surgery within the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Run-in Period

Participants are trained on the use of the DPI and nebulizer, complete daily diaries, and undergo vital signs and physical examination

1 week

1 visit (in-person)

Treatment

Participants receive assigned treatment (DPI or nebulizer) for 12 weeks with monitoring and follow-up calls at weeks 4 and 8

12 weeks

1 visit (in-person), 2 phone visits

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Formoterol
• Revefenacin
• Umeclidinium
• Vilanterol

Trial Overview The study compares two methods of delivering long-acting bronchodilators: nebulizers versus dry powder inhalers (DPIs). It tests whether nebulized LAMA/LABA improves lung inflation and reduces COPD symptoms more effectively than DPI-administered LAMA/LABA.

How Is the Trial Designed?

Group I: Nebulizer Treatment Group Active Control 2 Interventions

Group B: Receives revefenacin 175 µg and formoterol 20 µg via nebulizer and placebo DPI at treatment visit # 2 and will continue with assigned treatment and placebo for 12 weeks

Group II: DPI Treatment Group Active Control 2 Interventions

Group A: Receives Umeclidinium 62.5 µg and Vilanterol 25 µg via DPI and Revefenacin placebo and formoterol placebo (sterile normal saline) via nebulizer at treatment visit # 2 and will continue with assigned treatment and placebo for 12 weeks

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials

17

Recruited

1,400+

Theravance Biopharma

Industry Sponsor

Trials

74

Recruited

8,600+

Rick E. Winningham

Theravance Biopharma

Chief Executive Officer since 2014

Bachelor's degree in Economics from Southern Methodist University

Laurie Smaldone Alsup

Theravance Biopharma

Chief Medical Officer since 2018

MD from McGill University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7454021/

Safety and Efficacy of Revefenacin and Formoterol in ... Revefenacin inhalation solution is a once-daily LAMA delivered by a standard jet nebulizer that is approved by the US Food and Drug Administration.

2. chestpulmonary.org chestpulmonary.org/article/S2949-7892(24)00071-0/fulltext

Safety, Efficacy, and Feasibility of Nebulized Long-Acting ... Formoterol twice daily combined with revefenacin once daily has been shown to provide sustained bronchodilation in patients with stable COPD.

3. journal.copdfoundation.org journal.copdfoundation.org/jcopdf/id/1230/Improvements-in-Lung-Function-with-Nebulized-Revefenacin-in-the-Treatment-of-Patients-with-Moderate-to-Very-Severe-COPD-Results-from-Two-Replicate-Phase-III-Clinical-Trials

Phase III Trials of Revefenacin in COPD Patients Revefenacin is a novel, once-daily, lung-selective LAMA in late-stage clinical development for the treatment of patients with COPD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052452/

Efficacy and safety of revefenacin for nebulization in ... Altogether, our results demonstrate that revefenacin for nebulization significantly improved lung function (trough FEV1) and health outcomes (total SGRQ scores) ...

5. publications.ersnet.org publications.ersnet.org/content/erj/52/suppl62/oa1655

COPD exacerbations in the phase 3 revefenacin clinical trial ... Conclusions: Analyses of ph3 data indicate that once-daily REV for up to 52 wks was associated with a reduction in COPD exacerbation in patients with moderate ...

6. yupelrihcp.com yupelrihcp.com/efficacy-and-safety

Efficacy & Safety - YUPELRI® (revefenacin) inhalation solution View Safety Data ... YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094553918303067

Cardiovascular safety of revefenacin, a once-daily, lung ... Thus, revefenacin may provide beneficial nebulized therapy for patients with moderate to very severe COPD without further elevating their risk of CV events.