Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators

NCT07133880 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 4889Institutional Review Board
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted). The investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent/long-acting beta agonist (LAMA/LABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA/LABA therapy given by a DPI. The study aims to demonstrate the following:

1. 1.Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer
2. 2.Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline/Transition Dyspnea Index (BDI/TDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference Between the Values of Area Under the Response Curve for Inspiratory Capacity (IC)

  Difference between the values of area under the response curve for inspiratory capacity (IC) from baseline through six hours (AUC IC 0-6h) after inhalation of LAMA/LABA combination with a nebulizer versus a DPI OR Proportion of participants achieving improvement of \>2 points in their CAT score compared to baseline OR Proportion of participants achieving reduction of 4 points in SGRQ score compared to baseline

  From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12)

Secondary Outcomes (14)

• Percentage change in Residual Volume (RV) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI

  From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)

• Percentage change in Total Lung Capacity (TLC) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI

  From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)

• Percentage change in airway resistance (Raw) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI

  From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)

• Maximum percentage change in inspiratory capacity between 0 and 6 hours after LAMA/LABA combination with a nebulizer versus a DPI

  From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)

• Maximum percentage change in RV between 0 and 6 hours after LAMA/LABA combination

  From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)

Study Arms (2)

DPI Treatment Group

ACTIVE COMPARATOR

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

Drug: umeclidinium 62.5 µg and vilanterol 25 µg; Drug: Placebo ( Revefenacin and Formoterol )

Nebulizer Treatment Group

ACTIVE COMPARATOR

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

Drug: Revefenacin 175 µg, Formoterol 20 µg; Drug: Placebo DPI

Interventions

umeclidinium 62.5 µg and vilanterol 25 µg DRUG

DPI Treatment

Also known as: Anoro Ellipta

DPI Treatment Group

Revefenacin 175 µg, Formoterol 20 µg DRUG

Nebulizer Treatment

Also known as: Yupelri, Perforomist

Nebulizer Treatment Group

Placebo ( Revefenacin and Formoterol ) DRUG

Placebo Nebulizer Treatment

Also known as: Normal Saline

DPI Treatment Group

Placebo DPI DRUG

Placebo DPI Treatment

Nebulizer Treatment Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diagnosis of asthma (Verification via medical record and/or patient report)
• 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)
• Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)
• Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)
• Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
• Recent (within 8 weeks) h/o eye surgery (Verification via medical record and/or patient report)
• Uncontrolled glaucoma (Verification via medical record and/or patient report)
• Known diagnosis of liver cirrhosis (Verification via medical record and/or patient report)
• Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report)
• Intolerance to any of the study drugs
• Patients receiving long-term azithromycin
• Planned surgery requiring hospital admission within 3 months
• Currently enrolled in a pulmonary rehabilitation program
• Inability to give informed consent
• 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)

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Theravance Biopharma: collaborator

Study Sites (1)

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719; vilanterol; revefenacin; Formoterol Fumarate; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 21, 2025
• Study Start: December 5, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)