Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
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
Interventions
Nebulized therapy of similar medication solutions
Continue handheld therapy
Conditions
Locations
Midwest Chest Consultants, P.C.
Saint Charles, Missouri 63301
United States
Southeastern Research Center
Winston-Salem, North Carolina 27103
United States