Nebulized vs handheld maintenance therapy for COPD patients with limited benefit from inhalers
Official title: Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
Run by COPD Foundation · NCT07816835 · Data updated 2026-11-12
This trial tests whether switching to a breath-enhanced nebulizer with similar COPD meds helps people who don’t get enough relief from their current handheld inhalers.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | COPD Foundation Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 2 sites (Saint Charles, Missouri and 1 other locations) |
| Status | Recruiting |
| Started | July 14, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT07816835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe to very severe COPD who are on LABA/LAMA or LABA/LAMA/ICS via handheld devices and report little symptomatic benefit.
✕Probably not a fit
Patients who respond well to handheld inhalers or have conditions limiting nebulizer use may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In adults with severe to very severe COPD, it compares nebulized long-acting maintenance medications to continuing handheld inhaler therapy. The study is randomized and multi-site, aiming to see if nebulized delivery improves dyspnea and overall health status. Participants must be stable COPD patients already using LABA/LAMA or LABA/LAMA/ICS therapies and with reduced FEV1, despite daily inhaler use. The hypothesis is that differing particle sizes and improved delivery with a nebulizer may lead to better bronchodilation and symptom control. Exclusions include cognitive impairment, severe dexterity issues, recent COPD flare-ups, other significant respiratory diseases, or daily systemic steroids for COPD.
Why it matters
Potential benefit: If successful, patients may experience better breathlessness control and improved quality of life with nebulized maintenance therapy.
How similar studies have gone: Previous work in COPD has explored alternative delivery methods; this study tests a similar concept with breath-enhanced jet nebulizers in a defined subgroup.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
Midwest Chest Consultants, P.C.
Saint Charles, Missouri, United States Recruiting -
Southeastern Research Center
Winston-Salem, North Carolina, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.