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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
University of Tennessee Graduate School of Medicine
Study ID
NCT07133880
Phase
PHASE4
Status
Recruiting
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Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • umeclidinium 62.5 µg and vilanterol 25 µg — DRUG
    DPI Treatment
  • Revefenacin 175 µg, Formoterol 20 µg — DRUG
    Nebulizer Treatment
  • Placebo ( Revefenacin and Formoterol ) — DRUG
    Placebo Nebulizer Treatment
  • Placebo DPI — DRUG
    Placebo DPI Treatment

Study Details

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

Key Dates

Start date
Dec 5, 2023
Status verified
Aug 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Tennessee Graduate School of MedicineKnoxvilleTennessee37920
Tracy Walker, Study Coordinator
[email protected]
865-305-4297
Rajiv Dhand, MD (PRINCIPAL_INVESTIGATOR)
Isaac Biney, MD (SUB_INVESTIGATOR)
Samuel Treat, MD (SUB_INVESTIGATOR)
Paul Terry, PhD (SUB_INVESTIGATOR)

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By research site
The University of Tennessee Graduate School of Medicine· Knoxville, TN

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