Status:
RECRUITING
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Collaborating Sponsors:
Theravance Biopharma
Conditions:
COPD (Chronic Obstructive Pulmonary Disease)
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 Pulmon...
Detailed Description
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 dai...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07133880
Start Date
December 5 2023
End Date
December 1 2025
Last Update
August 27 2025
Active Locations (1)
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1
The University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920