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Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

RECRUITINGPhase 4Sponsored by COPD Foundation
Actively Recruiting
PhasePhase 4
SponsorCOPD Foundation
Started2026-07-14
Est. completion2027-06
Eligibility
Age60 Years+
Healthy vol.Accepted
Locations2 sites

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.

Eligibility

Age: 60 Years+Healthy volunteers accepted
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

Conditions3

COPDCOPD - Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)

Locations2 sites

Missouri

1 site
Midwest Chest Consultants, P.C.
Saint Charles, Missouri, 63301
Thomas M Siler, MD636-946-1650thomas.siler.md@midwestchest.com

North Carolina

1 site
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Benjamin Bregman, MD336-659-8414bbregman@southeasternresearchcenter.com

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