Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
Eligible age
40+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: University of Tennessee Graduate School of Medicine
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Knoxville
Source: ClinicalTrials.gov · NCT07133880 · last updated 2025-08-27