Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

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.

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