Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
Purpose
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.
Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Chronic Obstructive Pulmonary Disease (COPD)
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized to continue handheld therapy or switch to nebulized delivery
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- DELIVERY is an open-label study with an outcomes assessor blinded to treatment arm.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Handheld Inhaler Group |
Subjects continue with their current maintenance handheld inhaler regimen |
|
|
Active Comparator Nebulizer Group |
Subjects switched to nebulized therapy using similar medication solutions |
|
Recruiting Locations
Saint Charles, Missouri 63301
Winston-Salem, North Carolina 27103
More Details
- Status
- Recruiting
- Sponsor
- COPD Foundation
Study Contact
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.