A Phase 4 interventional study of Nebulized therapy of similar medication solutions and Continue handheld therapy in COPD (Chronic Obstructive Pulmonary Disease) and Chronic Obstructive Pulmonary Disease (COPD), sponsored by COPD Foundation. Recruiting at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by COPD Foundation · Phase 4, Interventional, and Treatment
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →COPD Foundation is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects continue with their current maintenance handheld inhaler regimen
Device: Continue handheld therapy
Subjects switched to nebulized therapy using similar medication solutions
Device: Nebulized therapy of similar medication solutions
LABA/LAMA or LABA/LAMA/ICS nebulized solutions
Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy
Transition Dyspnea Index
Measurement of dyspnea
Time frame: 28 (+/- 2) days
FEV1 and FVC
Changes in lung function
Time frame: 28 (+/- 2) days
Plan to share: Yes — Demographic data and Transition Dyspnea Index
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Upon completion of study, anticipated January 2028. For 6 months
Data sharing details ↗ · copdfoundation.org
Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.
Of 86 non-industry phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 11 months is below that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Pulmonary Disease, Chronic Obstructive →
COPD Foundation