COPD (Chronic Obstructive Pulmonary Disease)Phase 4DELIVERYNCT07816835
Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
A Phase 4 study testing Nebulized therapy of similar medication solutions and Continue handheld therapy in people with COPD (Chronic Obstructive Pulmonary Disease) and Chronic Obstructive Pulmonary Disease (COPD), run by COPD Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Nebulized therapy of similar medication solutions and Continue handheld therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Midwest Chest Consultants, P.C.
Saint Charles, Missouri, 63301
Thomas M Siler, MD, 636-946-1650, thomas.siler.md@midwestchest.com
Krista Muller, CCRC
- Recruiting
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Benjamin Bregman, MD, 336-659-8414, bbregman@southeasternresearchcenter.com
Karen McCutcheon, BS, CRCC
About this study
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.
Read the 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.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Chronic Obstructive Pulmonary Disease (COPD)
- Being tested
- Nebulized therapy of similar medication solutions, Continue handheld therapy
- Keywords
- COPD, BDI, TDI, COPD maintenance therapy, Nebulizer therapy, LABA/LAMA, LABA/LAMA/ICS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized therapy of similar medication solutionsDevice
LABA/LAMA or LABA/LAMA/ICS nebulized solutions
Continue handheld therapyDevice
Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy
| Study group | Role | What they receive |
|---|---|---|
| Handheld Inhaler Group | Other | Subjects continue with their current maintenance handheld inhaler regimen Receives: Device: Continue handheld therapy |
| Nebulizer Group | Active comparator | Subjects switched to nebulized therapy using similar medication solutions Receives: Device: Nebulized therapy of similar medication solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition Dyspnea Index
Measurement of dyspnea
Measured: 28 (+/- 2) days
Secondary outcomes (1)
FEV1 and FVC
Changes in lung function
Measured: 28 (+/- 2) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start14 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to continue handheld therapy or switch to nebulized delivery
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- COPD Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Viatris Specialty LLC, PARI Respiratory Equipment, Inc., Theravance Biopharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816835
- Sponsor's protocol ID
- 2025-DELIVERY
- Acronym
- DELIVERY
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Demographic data and Transition Dyspnea Index
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
- ClinicalTrials.gov ID
- NCT07816835
- Acronym / sponsor ID
- DELIVERY / 2025-DELIVERY
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Chronic Obstructive Pulmonary Disease (COPD)
- Keywords
- COPD, BDI, TDI, COPD maintenance therapy, Nebulizer therapy, LABA/LAMA, LABA/LAMA/ICS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- COPD FoundationUniversity, hospital or other
- Collaborators
- Viatris Specialty LLC, PARI Respiratory Equipment, Inc., Theravance Biopharma
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to continue handheld therapy or switch to nebulized delivery
| Arm | Type | Receives |
|---|---|---|
| Handheld Inhaler Group | Other | Device: Continue handheld therapySubjects continue with their current maintenance handheld inhaler regimen |
| Nebulizer Group | Active comparator | Device: Nebulized therapy of similar medication solutionsSubjects switched to nebulized therapy using similar medication solutions |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized therapy of similar medication solutionsLABA/LAMA or LABA/LAMA/ICS nebulized solutions | Device | Nebulizer Group |
| Continue handheld therapyContinue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy | Device | Handheld Inhaler Group |
Primary outcome
Transition Dyspnea Index
Time frame: 28 (+/- 2) days
Measurement of dyspnea
1 secondary outcome
FEV1 and FVC
Time frame: 28 (+/- 2) days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Demographic data and Transition Dyspnea Index
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Midwest Chest Consultants, P.C.
Saint Charles, United States
Southeastern Research Center
Winston-Salem, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized therapy of similar medication solutions and Continue handheld therapy in people with COPD (Chronic Obstructive Pulmonary Disease) and Chronic Obstructive Pulmonary Disease (COPD), run by COPD Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition Dyspnea Index (time frame: 28 (+/- 2) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.