Actively Recruiting
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
Led by University of Tennessee Graduate School of Medicine · Updated on 2025-08-27
72
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
U
University of Tennessee Graduate School of Medicine
Lead Sponsor
T
Theravance Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 40 years
- Any gender
- Current smoker or past smoking history of more than 10 pack-years
- Symptoms of COPD such as cough, sputum production, or shortness of breath
- Modified Medical Research Council Dyspnea Scale (mMRC) score 2 or higher or COPD Assessment Test (CAT) score 10 or higher at screening
- Peak inspiratory flow rate (PIFR) greater than 30 at screening
- FEV1/FVC ratio less than 70% within the past 12 months
- Residual volume (RV) 120% or more of predicted within the past 12 months
You will not qualify if you...
- Diagnosis of asthma
- History of atrial fibrillation with rapid ventricular response or ventricular arrhythmia
- Acute myocardial infarction within 12 weeks before study registration
- Acute worsening of congestive heart failure
- Acute exacerbation of COPD within 8 weeks before study registration
- Eye surgery within 8 weeks before study registration
- Uncontrolled glaucoma
- Known liver cirrhosis
- Known chronic kidney insufficiency with serum creatinine over 2.5 mg/dL
- Intolerance to any study drugs
- Receiving long-term azithromycin treatment
- Planned surgery requiring hospital admission within 3 months
- Currently in a pulmonary rehabilitation program
- Unable to provide informed consent
- Pregnant, nursing, or women not using approved contraception
- Unable to understand or follow study instructions
- Participation in another investigational drug trial within 30 days prior to study
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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