Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchod… (NCT07133880) | Clinical Trial Compass
RecruitingPhase 4
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
United States72 participantsStarted 2023-12-05
Plain-language 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
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Age \> 40 years
✓. Either sex
✓. Current smoker or past cigarette smoking history of \> 10 pack-years
✓. Symptoms of COPD (cough, sputum production, shortness of breath)
✓. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening/Run-in visit
✓. A PIFR \> 30 at screening
✓. FEV1/FVC ratio \< 70% (within the past 12 months)
✓. Residual volume (RV) ≥ 120% predicted (within the past 12 months
Exclusion criteria
✕. Diagnosis of asthma (Verification via medical record and/or patient report)
✕. 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)
What they're measuring
1
Difference Between the Values of Area Under the Response Curve for Inspiratory Capacity (IC)
Timeframe: From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12)
Trial details
NCT IDNCT07133880
SponsorUniversity of Tennessee Graduate School of Medicine