Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD (DELIVERY)

Multi-site, randomized controlled trial to determine whether patients who report NO symptomatic benefit with their maintenance hand-held inhaler(s), benefit upon switching to nebulized therapy using comparable classes of medications.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Device: Continue handheld therapy; Device: Nebulized therapy of similar medication solutions

Detailed Description

In stable out-patients with an established diagnosis of severe to very severe COPD the hypothesis is that delivery of similar long-acting, maintenance medications via a breath-enhanced jet nebulizer provides significant improvements in ratings of dyspnea and health status compared with continuing therapy with handheld device(s).

This hypothesized benefit could be due to:

Patients with severe to very severe COPD may not consistently use their handheld inhaler(s) correctly every day and therefore not achieve optimal bronchodilation/symptom benefit; and/or A breath-enhanced jet nebulizer can deliver smaller size particles and a greater fine particle fraction (< 5 μm) than handheld therapy in patients with COPD using Acceptable technique.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Recruiting
      • Midwest Chest Consultants, P.C.
      • Contact: Thomas M Siler, MD; Phone Number: 636-946-1650; Email: thomas.siler.md@midwestchest.com
      • Contact: Krista Muller, CCRC
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Southeastern Research Center
      • Contact: Benjamin Bregman, MD; Phone Number: 336-659-8414; Email: bbregman@southeasternresearchcenter.com
      • Contact: Karen McCutcheon, BS, CRCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• > 10 pack-years smoking cigarettes
• Diagnosis of COPD based on GOLD Criteria
• Patients are clinically stable for the past 4 weeks
• Prior Pulmonary function tests showing FEV1 < 50% predicted (either 30 minutes post albuterol or within 2-4 hours after using their maintenance long-acting inhaler) within the past 12 months.
• Currently using a single pMDI or a single DPI with either LABA/LAMA or LABA/LAMA/ICS therapy for at least one month.

Exclusion Criteria:

• Current diagnosis of dementia or known cognitive impairment.
• Current impairment in manual dexterity (i.e., severe rheumatoid arthritis, severe tremor, etc)
• Exacerbation of COPD within the last 2 months
• Current diagnosis of other respiratory disease including asthma, treatment with a LABA/LAMA slow mist inhaler or treatment with SABA/SAMA nebulizer medications 3-4 times per day as maintenance therapy
• Current use of daily Prednisone as treatment for COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Handheld Inhaler Group; Subjects continue with their current maintenance handheld inhaler regimen	Device: Continue handheld therapy; Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy
Active Comparator: Nebulizer Group; Subjects switched to nebulized therapy using similar medication solutions	Device: Nebulized therapy of similar medication solutions; LABA/LAMA or LABA/LAMA/ICS nebulized solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transition Dyspnea Index	Measurement of dyspnea	28 (+/- 2) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 and FVC	Changes in lung function	28 (+/- 2) days

Collaborators and Investigators

• Sponsor: COPD Foundation
• Collaborators: Theravance Biopharma; Viatris Specialty LLC; PARI Respiratory Equipment, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 8, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: LABA/LAMA; COPD, BDI, TDI; COPD maintenance therapy; Nebulizer therapy; LABA/LAMA/ICS
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2025-DELIVERY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic data and Transition Dyspnea Index
• IPD Sharing Time Frame: Upon completion of study, anticipated January 2028. For 6 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No