Nebulizer versus dry-powder inhaler long-acting bronchodilator treatment for COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-dummy, parallel-group Phase 4 trial that will run 13 weeks and compare umeclidinium/vilanterol delivered by DPI to revefenacin/formoterol given by nebulizer in symptomatic, stable COPD patients with airflow obstruction and elevated residual volume. Participants undergo a screening and run-in, device training, daily symptom and medication diaries, and baseline and follow-up pulmonary function testing including inspiratory flow measurement with an In-Check DIAL. The primary physiologic endpoints include changes in inspiratory capacity and residual volume, and patient-reported outcomes include CAT, BDI/TDI, and SGRQ scores. The study is single-center at the University of Tennessee Graduate School of Medicine with industry collaboration and excludes patients with asthma, recent major cardiac events, or unstable arrhythmias.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 40 years
2. Either sex
3. Current smoker or past cigarette smoking history of \> 10 pack-years
4. Symptoms of COPD (cough, sputum production, shortness of breath)
5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening/Run-in visit
6. A PIFR \> 30 at screening
7. FEV1/FVC ratio \< 70% (within the past 12 months)
8. Residual volume (RV) ≥ 120% predicted (within the past 12 months

Exclusion Criteria:

1. Diagnosis of asthma (Verification via medical record and/or patient report)
2. 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)
3. Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)
4. Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)
5. Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
6. Recent (within 8 weeks) h/o eye surgery (Verification via medical record and/or patient report)
7. Uncontrolled glaucoma (Verification via medical record and/or patient report)
8. Known diagnosis of liver cirrhosis (Verification via medical record and/or patient report)
9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report)
10. Intolerance to any of the study drugs
11. Patients receiving long-term azithromycin
12. Planned surgery requiring hospital admission within 3 months
13. Currently enrolled in a pulmonary rehabilitation program
14. Inability to give informed consent
15. 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)
16. Inability to understand instructions or comply with the study protocol
17. 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

Where it's running

• The University of Tennessee Graduate School of Medicine
  Knoxville, Tennessee, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.