NCT07133880RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 5 Dec 2023
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Diseases
- COPD
- NCT number
- NCT07133880
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 72
- From 5 Dec 2023 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Recent (within 8 weeks) h/o eye surgery (Verification via medical record and/or patient report)
- Intolerance to any of the study drugs
- Patients receiving long-term azithromycin
- Planned surgery requiring hospital admission within 3 months
- 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)
- 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
Other illness
- Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)
- Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)
Lab values
- Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report)
Other
- Diagnosis of asthma (Verification via medical record and/or patient report)
- Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
- Uncontrolled glaucoma (Verification via medical record and/or patient report)
- Known diagnosis of liver cirrhosis (Verification via medical record and/or patient report)
- Currently enrolled in a pulmonary rehabilitation program
- Inability to give informed consent
- Inability to understand instructions or comply with the study protocol
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Tennessee Graduate School of Medicine Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.