Nebulizer versus dry-powder inhaler long-acting bronchodilator treatment for COPD

Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease

This study will test whether a nebulized long-acting bronchodilator combination helps people with symptomatic COPD and air trapping breathe better than the same medicines given by a dry powder inhaler.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of Tennessee Graduate School of Medicine (Academic / other)
• Locations: 1 site (Knoxville, Tennessee)
• Trial ID: NCT07133880 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-dummy, parallel-group Phase 4 trial that will run 13 weeks and compare umeclidinium/vilanterol delivered by DPI to revefenacin/formoterol given by nebulizer in symptomatic, stable COPD patients with airflow obstruction and elevated residual volume. Participants undergo a screening and run-in, device training, daily symptom and medication diaries, and baseline and follow-up pulmonary function testing including inspiratory flow measurement with an In-Check DIAL. The primary physiologic endpoints include changes in inspiratory capacity and residual volume, and patient-reported outcomes include CAT, BDI/TDI, and SGRQ scores. The study is single-center at the University of Tennessee Graduate School of Medicine with industry collaboration and excludes patients with asthma, recent major cardiac events, or unstable arrhythmias.

Who should consider this trial

Good fit: Ideal candidates are adults over 40 with symptomatic COPD, a >10 pack-year smoking history, FEV1/FVC <70%, residual volume ≥120% predicted, PIFR >30, and an mMRC ≥2 or CAT ≥10 who can attend clinic visits and complete study procedures.

Not a fit: Patients with a diagnosis of asthma, recent myocardial infarction, unstable ventricular arrhythmia, recent exacerbation of heart failure, or those without measurable air trapping are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, nebulized LAMA/LABA therapy could reduce lung hyperinflation and improve breathing and symptoms more than DPI therapy for some people with COPD.

How similar studies have performed: Nebulized bronchodilators have shown benefit for some COPD patients with low inspiratory flow, but direct head-to-head data comparing nebulized LAMA/LABA combos to DPI delivery are limited.

Eligibility criteria

Inclusion Criteria:

1. Age \> 40 years
2. Either sex
3. Current smoker or past cigarette smoking history of \> 10 pack-years
4. Symptoms of COPD (cough, sputum production, shortness of breath)
5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening/Run-in visit
6. A PIFR \> 30 at screening
7. FEV1/FVC ratio \< 70% (within the past 12 months)
8. Residual volume (RV) ≥ 120% predicted (within the past 12 months

Exclusion Criteria:

1. Diagnosis of asthma (Verification via medical record and/or patient report)
2. Previously diagnosed atrial fibrillation with rapid ventricular response (heart rate \> 110 bpm) or ventricular arrhythmia (ventricular tachycardia) (Verification via medical record and/or patient report)
3. Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)
4. Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)
5. Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
6. Recent (within 8 weeks) h/o eye surgery (Verification via medical record and/or patient report)
7. Uncontrolled glaucoma (Verification via medical record and/or patient report)
8. Known diagnosis of liver cirrhosis (Verification via medical record and/or patient report)
9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report)
10. Intolerance to any of the study drugs
11. Patients receiving long-term azithromycin
12. Planned surgery requiring hospital admission within 3 months
13. Currently enrolled in a pulmonary rehabilitation program
14. Inability to give informed consent
15. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants)
16. Inability to understand instructions or comply with the study protocol
17. Participation in another investigational drug clinical trial within 30 days of patient study registration

Medical history can be confirmed by medical records and/or verbal confirmation from patients. However, Inclusion criteria 6 \& 7 must be verified by a previous PFT report dated within 6 months of screening

Where this trial is running

Knoxville, Tennessee

• The University of Tennessee Graduate School of Medicine — Knoxville, Tennessee, United States (Recruiting)

Conditions COPD; Chronic Obstructive Pulmonary Disease; Nebulizer; Dry Powder Inhaler