Chronic Obstructive Pulmonary Disease (COPD), COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, BDI, TDI, COPD maintenance therapy, Nebulizer therapy, LABA/LAMA, LABA/LAMA/ICS
Brief 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.
Interventions
DEVICENebulized therapy of similar medication solutions
LABA/LAMA or LABA/LAMA/ICS nebulized solutions
DEVICEContinue handheld therapy
Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy
Sponsors
COPD Foundation
Viatris Specialty LLC
PARI Respiratory Equipment, Inc.
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
DELIVERY is an open-label study with an outcomes assessor blinded to treatment arm.
Intervention model description
Randomized to continue handheld therapy or switch to nebulized delivery
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition Dyspnea Index | 28 (+/- 2) days | Measurement of dyspnea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 and FVC | 28 (+/- 2) days | Changes in lung function |
Countries
United States
Outcome results
None listed