Recruiting

LAMA/LABA vs. DPI

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT07133880

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

umeclidinium 62.5 µg and vilanterol 25 µg

Revefenacin 175 µg, Formoterol 20 µg

Placebo ( Revefenacin and Formoterol )

Placebo DPI

Study Details

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. 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. 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)

Study ID

NCT07133880

Start date

Dec 5, 2023

Status verified date

Aug, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DPI Treatment Group

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

active comparator: Nebulizer Treatment Group

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

Interventions

umeclidinium 62.5 µg and vilanterol 25 µg

DPI Treatment

Revefenacin 175 µg, Formoterol 20 µg

Nebulizer Treatment

Placebo ( Revefenacin and Formoterol )

Placebo Nebulizer Treatment

Placebo DPI

Placebo DPI Treatment

Primary outcome measure

  • Difference Between the Values of Area Under the Response Curve for Inspiratory Capacity (IC) [ Time Frame: From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) ]

Central Contacts and Locations

Locations

The University of Tennessee Graduate School of Medicine

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Tracy Walker, Study Coordinator

865-305-4297twalker5@utmck.edu

Principal Investigator:

Rajiv Dhand, MD

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Aug 17, 2026

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2026-08-17.