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Blood test may help severe COPD patients safely reduce steroids

NCT ID NCT04481555

Disease control Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a personalized approach for people with severe COPD. Doctors used a simple blood test (eosinophil count) to decide whether to reduce inhaled steroids, and some patients also received the antibiotic azithromycin. The goal was to see if this strategy could reduce serious flare-ups and hospital stays. 444 patients took part, and the results could lead to safer, more tailored treatment plans.

What this could mean

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

Active substance
azithromycin and inhaled corticosteroids (ICS)
What this could lead to
If successful, this approach could help personalize COPD treatment, reducing unnecessary steroid use and preventing severe flare-ups.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all COPD patients. Azithromycin can cause antibiotic resistance and side effects like hearing loss or heart rhythm issues.

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

444 people

The number who actually took part.

Started

Jun 2021

Finished

Nov 2025

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

40 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: * COPD (verified by a specialist in respiratory medicine + spirometry) * GOLD class E anytime within the last 2 years (corresponding to 2 ≥ AECOPD and/or ≥1 AECOPD leading to hospitalization during a 12 months period within the last 2 years) and/or FEV1\<30%. * Treatment for last 4 weeks including LAMA, LABA and ICS * Informed consent Exclusion Criteria: * Known asthma. * Male \< 40 years. * Female \<40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test * Severe mental illness which considerably complicates co-operation. * Language problems that considerably complicate co-operation. * Current treatment with systemic corticosteroids corresponding to \> 5 mg prednisolone per day. * Systemic antibiotic treatment (if to participate in microbiota sub-study) or systemic corticosteroid treatment within 14 days (also prophylactic Azithromycin). * Contra-indication to treat with Azithromycin (as listed by the producer). * Non-bacterial exacerbation per investigator judgement in the last 3 months.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset pneumonia

As listed by the trial registrant

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

Azithromycin COPD COPD exacerbation Inhaled corticosteroid Pneumonia

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Gentofte Hospital

    Hellerup, Denmark

  • Hvidovre Hospital

    Copenhagen, Denmark

  • Nordsjællands Hospital

    Hillerød, Denmark

  • Næstved-Slagelse-Ringsted Sygehus

    Næstved, Denmark

  • Odense University Hospital

    Odense, Denmark

  • Roskilde Sygehus

    Roskilde, Denmark

  • Silkeborg Sygehus

    Silkeborg, Denmark

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, Denmark

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