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

What this Trial Is About

Researchers are comparing two ways of delivering long-acting bronchodilator medications to people with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction and significant air trapping. The study aims to see if using a nebulizer provides better improvement in lung hyperinflation and symptoms than using a dry powder inhaler (DPI). This phase four clinical trial focuses on patients with symptomatic, stable COPD. Participants will be randomly assigned to one of two groups for 12 weeks. Group A will receive umeclidinium and vilanterol via DPI plus placebo nebulizer treatments, while Group B will receive revefenacin and formoterol via nebulizer plus placebo DPI treatments. The study includes a screening visit, baseline assessments, and training on medication and diary use, followed by twice-daily treatments and telephone check-ins at weeks 4 and 8. During the study, participants will complete symptom diaries and questionnaires, undergo pulmonary function tests at baseline and week 12 with repeated measures after dosing, and have vital signs monitored. Researchers will measure inspiratory capacity, residual volume, and patient-reported outcomes such as the COPD Assessment Test (CAT), Baseline/Transition Dyspnea Index (BDI/TDI), and St. George Respiratory Questionnaire (SGRQ). The total study duration per participant is approximately 13 weeks with careful monitoring of medication adherence and safety.

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