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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
LABA/LAMA or LABA/LAMA/ICS nebulized solutions
Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy
Midwest Chest Consultants, P.C.
Saint Charles, Missouri, United States
RECRUITINGSoutheastern Research Center
Winston-Salem, North Carolina, United States
RECRUITINGTransition Dyspnea Index
Measurement of dyspnea
Time frame: 28 (+/- 2) days
FEV1 and FVC
Changes in lung function
Time frame: 28 (+/- 2) days
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