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Switching to a nebulizer may help COPD patients who get no relief from inhalers

NCT ID NCT07816835

Symptom relief Sponsor: COPD Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether COPD patients who report no symptom relief from their handheld maintenance inhalers do better when switched to nebulized versions of similar drugs. The trial enrolls about 120 people with severe COPD who have used a single handheld inhaler for at least a month. Participants are randomly assigned to either switch to nebulized LABA/LAMA or LABA/LAMA/ICS therapy or continue their current handheld therapy. The main measure is change in breathlessness, with lung function as a secondary measure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nebulized LABA/LAMA or LABA/LAMA/ICS solutions compared with continuing handheld inhaler therapy
What this could lead to
If nebulized therapy helps, it could give COPD patients who get no relief from handheld inhalers another way to ease breathlessness.
What could go wrong
The trial is small and only includes people with severe COPD who have not responded to handheld inhalers, so results may not apply to others. Nebulizers are bulkier and take longer to use than inhalers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease (COPD) COPD (chronic obstructive pulmonary disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Midwest Chest Consultants, P.C.

    RECRUITING

    Saint Charles, Missouri, 63301, United States

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

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