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RECRUITING Phase 4

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

NCT07133880 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 72 participants
Start Date 2023-12-05
Est. Completion 2025-12-01
Phase Phase 4

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee Graduate School of Medicine, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07133880 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07133880?

This trial is sponsored by University of Tennessee Graduate School of Medicine, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial