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

Description

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). We 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. We aim 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

COPD (Chronic Obstructive Pulmonary Disease)
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Related Conditions:

COPD (Chronic Obstructive Pulmonary Disease)

Study Overview

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Study Details

Study overview

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). We 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. We aim 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

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

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

Condition
COPD (Chronic Obstructive Pulmonary Disease)
Intervention / Treatment

-

Contacts and Locations

Knoxville

The University of Tennessee Graduate School of Medicine, Knoxville, Tennessee, United States, 37920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Tennessee Graduate School of Medicine,

Study Record Dates

2025-12-01