Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

NCT07816835 | Recruiting Phase 4 FDA Device

• 1 other identifier: 2025-DELIVERY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, BDI, TDI; COPD maintenance therapy; Nebulizer therapy; LABA/LAMA; LABA/LAMA/ICS

Outcome Measures

Primary Outcomes (1)

• Transition Dyspnea Index

  Measurement of dyspnea

  28 (+/- 2) days

Secondary Outcomes (1)

• FEV1 and FVC

  28 (+/- 2) days

Study Arms (2)

Handheld Inhaler Group

OTHER

Subjects continue with their current maintenance handheld inhaler regimen

Device: Continue handheld therapy

Nebulizer Group

ACTIVE COMPARATOR

Subjects switched to nebulized therapy using similar medication solutions

Device: Nebulized therapy of similar medication solutions

Interventions

Nebulized therapy of similar medication solutions DEVICE

LABA/LAMA or LABA/LAMA/ICS nebulized solutions

Nebulizer Group

Continue handheld therapy DEVICE

Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy

Handheld Inhaler Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theravance Biopharma: collaborator
• PARI Respiratory Equipment, Inc.: collaborator
• COPD Foundation: lead
• Viatris Specialty LLC: collaborator

Study Sites (2)

Midwest Chest Consultants, P.C.

Saint Charles, Missouri, 63301, United States

RECRUITING

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: DELIVERY is an open-label study with an outcomes assessor blinded to treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized to continue handheld therapy or switch to nebulized delivery

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon completion of study, anticipated January 2028. For 6 months

Locations

US (2)