Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
COPD Foundation
With
Viatris Specialty LLC
PARI Respiratory Equipment, Inc.
Theravance Biopharma
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.
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\> 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.
You may not be if
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
