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Die klinische Studie NCT07133880 für COPD (Chronisch obstruktive Lungenerkrankung) ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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University of TennesseeCompare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators Phase 4 72
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Die klinische Studie NCT07133880 untersucht Behandlung im Zusammenhang mit COPD (Chronisch obstruktive Lungenerkrankung). Diese interventionsstudie der Phase 4 hat den Status offene rekrutierung und startete am 5. Dezember 2023. Es ist geplant, 72 Teilnehmer aufzunehmen. Durchgeführt von University of Tennessee wird der Abschluss für 1. Dezember 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. August 2025 aktualisiert.
Kurzbeschreibung
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-act...
Mehr anzeigenAusführliche Beschreibung
This is a prospective, randomized, parallel group, double dummy, phase four, 13-week clinical trial with 1:1 allocation comparing long-acting anti-muscarinic agent (LAMA; Umeclidinium 62.5 μg once daily) and long acting beta-agonist (LABA; Vilanterol 25 μg once daily) delivered by DPI (Group A), vs a nebulized LAMA/LABA combination (revefenacin 175 μg once daily and formoterol 20 μg twice daily) (Group B) among sympt...Mehr anzeigen
Offizieller Titel
Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease
Erkrankungen
COPD (Chronisch obstruktive Lungenerkrankung)Weitere Studien-IDs
- 4889
- Institutional Review Board (Andere Kennung) (The University of Tennessee Health Science Center)
NCT-Nummer
Studienbeginn (tatsächlich)
2023-12-05
Zuletzt aktualisiert
2025-08-27
Studienende (vorauss.)
2025-12-01
Geplante Rekrutierung
72
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Offene Rekrutierung
Stichwörter
Chronic Obstructive Pulmonary Disease
COPD
Nebulizer
Dry Powder Inhaler
COPD
Nebulizer
Dry Powder Inhaler
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives VergleichspräparatDPI Treatment Group Group A: Receives Umeclidinium 62.5 µg and Vilanterol 25 µg via DPI and Revefenacin placebo and formoterol placebo (sterile normal saline) via nebulizer at treatment visit # 2 and will continue with assigned treatment and placebo for 12 weeks | umeclidinium 62.5 µg and vilanterol 25 µg DPI Treatment Placebo ( Revefenacin and Formoterol ) Placebo Nebulizer Treatment |
Aktives VergleichspräparatNebulizer Treatment Group Group B: Receives revefenacin 175 µg and formoterol 20 µg via nebulizer and placebo DPI at treatment visit # 2 and will continue with assigned treatment and placebo for 12 weeks | Revefenacin 175 µg, Formoterol 20 µg Nebulizer Treatment Placebo DPI Placebo DPI Treatment |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Difference Between the Values of Area Under the Response Curve for Inspiratory Capacity (IC) | 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 | From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Percentage change in Residual Volume (RV) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Percentage change in Total Lung Capacity (TLC) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Percentage change in airway resistance (Raw) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Maximum percentage change in inspiratory capacity between 0 and 6 hours after LAMA/LABA combination with a nebulizer versus a DPI | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Maximum percentage change in RV between 0 and 6 hours after LAMA/LABA combination | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Maximum Percentage Change in Airway Resistance (Raw) between 0 and 6 hours after LAMA/LABA | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Correlation of peak inspiratory flow rate with peak IC change from baseline | From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12) | |
Comparison of CAT scores in patients receiving medications with DPI vs nebulizer | From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) | |
Comparison of SGRQ scores in patients receiving medications with DPI vs nebulizer | At baseline (Visit 2, Week 2), and at study completion (Visit 3, Week 12) | |
Change in TDI in patients receiving medications with DPI vs nebulizer | Measured at Week 4 (Phone Visit 1), Week 8 (Phone Visit 2), and Week 12 (Study Visit 3) | |
Change in CAT scores in patients receiving medications with DPI vs nebulizer | From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12) | |
Change in SGRQ scores in patients receiving medications with DPI vs nebulizer | Measured at study visit 2 at week 2 and study completion visit 3 at week 12 | |
Correlation of CAT with LF and LH change (inspiratory capacity and residual volume change) with patient-reported outcomes including the SGRQ and the TDI | Baseline (Visit 2) through Study Completion (Visit 3 / Week 12) | |
Correlation of LH with patient-reported outcomes including scores from the CAT, SGRQ and TDI | Baseline (Visit 2) through Study Completion (Visit 3 / Week 12) |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
40 Years
Zugelassene Geschlechter
Alle
- 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
- Diagnosis of asthma (Verification via medical record and/or patient report)
- 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)
- 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)
- Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
- Recent (within 8 weeks) h/o eye surgery (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)
- Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine > 2.5 mg/dL - 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
- Currently enrolled in a pulmonary rehabilitation program
- Inability to give informed consent
- 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)
- Inability to understand instructions or comply with the study protocol
- 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
University of Tennessee69 aktive klinische Studien zum ErkundenTheravance BiopharmaKeine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Tennessee
The University of Tennessee Graduate School of Medicine, Knoxville, Tennessee, 37920, United States
Tracy Walker, Study Coordinator, Kontakt, 865-305-4297, [email protected]
Rajiv Dhand, MD, Hauptprüfer
Isaac Biney, MD, Prüfarzt
Samuel Treat, MD, Prüfarzt
Paul Terry, PhD, Prüfarzt
Offene Rekrutierung