Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07133880 · ClinicalTrials.gov registry record · Phase 4
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
A Phase 4 study of COPD (Chronic Obstructive Pulmonary Disease), sponsored by University of Tennessee Graduate School of Medicine.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT07133880: Recruiting Phase 4 study of COPD (Chronic Obstructive Pulmonary Disease), sponsored by University of Tennessee Graduate School of Medicine.
NCT07133880 is a Phase 4 study of COPD (Chronic Obstructive Pulmonary Disease) that is actively recruiting participants, run by University of Tennessee Graduate School of Medicine. The registered enrollment target is 72 participants, below the 727-participant average among 9 other COPD (Chronic Obstructive Pulmonary Disease) trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07133880, a Phase 4 study of COPD (Chronic Obstructive Pulmonary Disease), is actively recruiting participants, sponsored by University of Tennessee Graduate School of Medicine.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Difference between the values of area under the response curve for inspiratory capacity (IC) from baseline through six hours (AUC IC 0-6h) after inhalation of LAMA/LABA combination with a nebulizer versus a DPI OR Proportion of participants achieving improvement of \>2 points in their CAT score compared to baseline OR Proportion of participants achieving reduction of 4 points in SGRQ score compared to baseline
Conditions Studied
Interventions
- DRUG umeclidinium 62.5 µg and vilanterol 25 µg
- DRUG Revefenacin 175 µg, Formoterol 20 µg
- DRUG Placebo ( Revefenacin and Formoterol )
- DRUG Placebo DPI
Study Locations (1)
Tennessee
- The University of Tennessee Graduate School of Medicine - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-12-05 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 4 |
What NCT07133880 shows while recruiting
NCT07133880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 727-participant average among 9 other COPD (Chronic Obstructive Pulmonary Disease) trials with a reported enrollment target (90% lower).
The record links to 1 condition, with COPD (Chronic Obstructive Pulmonary Disease) appearing as the primary indexed condition, and to 4 interventions - of which umeclidinium 62.5 µg and vilanterol 25 µg is the first listed.
NCT07133880 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT07133880 about?
NCT07133880 is a clinical study titled "Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators". 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 (...
What is the current status of trial NCT07133880?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2023-12-05. Estimated completion is 2025-12-01.
What conditions does trial NCT07133880 study?
This clinical trial studies the following conditions: COPD (Chronic Obstructive Pulmonary Disease).
What interventions are being tested in trial NCT07133880?
The interventions under investigation include: umeclidinium 62.5 µg and vilanterol 25 µg (DRUG), Revefenacin 175 µg, Formoterol 20 µg (DRUG), Placebo ( Revefenacin and Formoterol ) (DRUG), Placebo DPI (DRUG).
Who is sponsoring clinical trial NCT07133880?
This trial is sponsored by University of Tennessee Graduate School of Medicine, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07133880 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COPD (Chronic Obstructive Pulmonary Disease)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07133880's enrollment target sits among peer trials
72 7th of 9 higher than 3 of 9 other COPD (Chronic Obstructive Pulmonary Disease) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COPD (Chronic Obstructive Pulmonary Disease) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
RECRUITING
-
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
RECRUITING · Phase 3
-
Photon-counting CT in Chest Imaging
RECRUITING · NA
-
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
RECRUITING · NA
-
Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation
RECRUITING · NA
-
Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI