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NCT07816835PHASE4Recruiting

Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

COPD Foundation

Start Date

7/14/2026

Completion Date

6/1/2027

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.

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.

Eligibility Criteria

Age Range: 60 years to No maximum

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

Interventions

DEVICE

Nebulized therapy of similar medication solutions

DEVICE

Continue handheld therapy

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Conditions

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

Locations

Midwest Chest Consultants, P.C.

Saint Charles, Missouri 63301

United States

Southeastern Research Center

Winston-Salem, North Carolina 27103

United States