RecruitingPhase 4NCT07133880

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

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

Sponsor

University of Tennessee Graduate School of Medicine

Enrollment

72 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

COPD, Chronic Obstructive Pulmonary Disease

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

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two delivery methods for COPD (chronic obstructive pulmonary disease) inhalers: a traditional nebulizer (a machine that turns liquid medicine into a mist) versus a standard inhaler device. The goal is to see which works better at opening airways and reducing symptoms in people with moderate-to-severe COPD. **You may be eligible if...** - You are over 40 years old - You are a current or former smoker (at least 10 pack-years of smoking history) - You have been diagnosed with COPD based on breathing tests - You have significant shortness of breath or COPD symptoms - Your breathing test shows airflow obstruction **You may NOT be eligible if...** - You have been diagnosed with asthma - You have uncontrolled heart rhythm problems - You have had a significant COPD flare-up (exacerbation) in the past month - You have severe heart, liver, or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.