RECRUITING

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

Talk to us

Conditions

COPD (Chronic Obstructive Pulmonary Disease)Chronic Obstructive Pulmonary DiseaseCOPDNebulizerDry Powder Inhaler

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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

Official Title

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

Quick Facts

Study Start:2023-12-05
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07133880

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.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> 40 years
  2. 2. Either sex
  3. 3. Current smoker or past cigarette smoking history of \> 10 pack-years
  4. 4. Symptoms of COPD (cough, sputum production, shortness of breath)
  5. 5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening/Run-in visit
  6. 6. A PIFR \> 30 at screening
  7. 7. FEV1/FVC ratio \< 70% (within the past 12 months)
  8. 8. Residual volume (RV) ≥ 120% predicted (within the past 12 months
  1. 1. Diagnosis of asthma (Verification via medical record and/or patient report)
  2. 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. 3. Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)
  4. 4. Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)
  5. 5. Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
  6. 6. Recent (within 8 weeks) h/o eye surgery (Verification via medical record and/or patient report)
  7. 7. Uncontrolled glaucoma (Verification via medical record and/or patient report)
  8. 8. Known diagnosis of liver cirrhosis (Verification via medical record and/or patient report)
  9. 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. 10. Intolerance to any of the study drugs
  11. 11. Patients receiving long-term azithromycin
  12. 12. Planned surgery requiring hospital admission within 3 months
  13. 13. Currently enrolled in a pulmonary rehabilitation program
  14. 14. Inability to give informed consent
  15. 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. 16. Inability to understand instructions or comply with the study protocol
  17. 17. Participation in another investigational drug clinical trial within 30 days of patient study registration

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Tennessee Graduate School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Chronic Obstructive Pulmonary Disease
  • COPD
  • Nebulizer
  • Dry Powder Inhaler

Additional Relevant MeSH Terms

  • COPD (Chronic Obstructive Pulmonary Disease)