RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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) 9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report) 10. Intolerance to any of the study drugs 11. Patients receiving long-term azithromycin 12. Planned surgery requiring hospital admission within 3 months 13. Currently enrolled in a pulmonary rehabilitation program 14. Inability to give willing to sign a consent form ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 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 Exclusion Criteria: 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) 9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report) 10. Intolerance to any of the study drugs 11. Patients receiving long-term azithromycin 12. Planned surgery requiring hospital admission within 3 months 13. Currently enrolled in a pulmonary rehabilitation program 14. Inability to give informed consent 15. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants) 16. Inability to understand instructions or comply with the study protocol 17. Participation in another investigational drug clinical trial within 30 days of patient study registration Medical history can be confirmed by medical records and/or verbal confirmation from patients. However, Inclusion criteria 6 \& 7 must be verified by a previous PFT report dated within 6 months of screening

Treatments Being Tested

DRUG

umeclidinium 62.5 µg and vilanterol 25 µg

DPI Treatment

DRUG

Revefenacin 175 µg, Formoterol 20 µg

Nebulizer Treatment

DRUG

Placebo ( Revefenacin and Formoterol )

Placebo Nebulizer Treatment

DRUG

Placebo DPI

Placebo DPI Treatment

Locations (1)

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, United States