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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07133880
The ClinicalTrials.gov registry entry for NCT07133880 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 727-participant average among 9 other COPD (Chronic Obstructive Pulmonary Disease) trials with a reported enrollment target (90% lower). The listed sponsor is University of Tennessee Graduate School of Medicine, which has 20 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.