NCT04481555CompletedPhase 4
Eosinophil-guided Reduction of Inhaled Corticosteroids
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid (ICS) therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD) receiving long-acting b-agonist (LABA) / long-acting muscarinic receptor antagonists (LAMA) / ICS treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 444 (actual)
- First submitted
- 14 Jul 2020
- Start date
- 28 Jun 2021
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Diseases
- COPD
- NCT number
- NCT04481555
- EU CT number
- 2022-501035-16-01
- EudraCT number
- 2020-003014-12
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 444
- From 28 Jun 2021 to the primary completion date, 27 Nov 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Severe mental illness which considerably complicates co-operation.
Age
- Male \< 40 years.
- Female \<40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test
Other
- Known asthma.
- Language problems that considerably complicate co-operation.
- Contra-indication to treat with Azithromycin (as listed by the producer).
- Non-bacterial exacerbation per investigator judgement in the last 3 months.
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Sydvestjysk Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Completed |
| Gentofte Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Completed |
| Nordsjaellands Hospital Coordinator of this site? Confirm its status | Hillerød | Denmark | Completed |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Completed |
| Næstved Hospital Coordinator of this site? Confirm its status | Naestved | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Roenne | Denmark | Completed |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Completed |
| Region Midtjylland Coordinator of this site? Confirm its status | Silkeborg | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.