NCT07816835 · COPD Foundation
Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
(DELIVERY)
What this study is about
Multi-site, randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
Nebulized therapy of similar medication solutions
LABA/LAMA or LABA/LAMA/ICS nebulized solutions
DEVICE
Continue handheld therapy
Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy
Primary outcome measures
Transition Dyspnea Index
Time frame: 28 (+/- 2) days
Measurement of dyspnea
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Saint Charles, Missouri
- Winston-Salem, North Carolina
Collaborators
Viatris Specialty LLC, PARI Respiratory Equipment, Inc., Theravance Biopharma
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations