Reducing inhaled corticosteroids guided by eosinophil levels in COPD patients

Eosinophil-guided Reduction of Inhaled Corticosteroids

This study is testing if lowering inhaled corticosteroids based on blood eosinophil levels can help people with severe COPD feel better while reducing side effects and if adding azithromycin can further improve their health.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 444 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark (Academic / other)
• Locations: 9 sites (Aarhus and 8 other locations)
• Trial ID: NCT04481555 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a personalized approach to reduce inhaled corticosteroid (ICS) therapy in patients with severe chronic obstructive pulmonary disease (COPD) based on their blood eosinophil levels. The study aims to determine if a reduction in ICS can decrease associated side effects while maintaining effective management of COPD exacerbations. Additionally, it evaluates the impact of prophylactic azithromycin treatment on reducing moderate to severe exacerbations and improving patient outcomes. The trial is randomized, double-blinded, and multicenter, adhering to good clinical practice principles.

Who should consider this trial

Good fit: Ideal candidates are adults with severe COPD who have experienced frequent exacerbations and are currently on a combination of long-acting bronchodilators and ICS.

Not a fit: Patients with asthma, those under 40 years of age, or individuals with severe mental illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could minimize ICS-related side effects and improve the quality of life for COPD patients.

How similar studies have performed: Previous studies have shown promising results with eosinophil-guided therapies in asthma and COPD, suggesting potential success for this novel approach.

Eligibility criteria

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.

Where this trial is running

Aarhus and 8 other locations

• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Hvidovre Hospital — Copenhagen, Denmark (Recruiting)
• Sydvestjysk Sygehus Esbjerg — Esbjerg, Denmark (Recruiting)
• Gentofte Hospital — Hellerup, Denmark (Recruiting)
• Nordsjællands Hospital — Hillerød, Denmark (Recruiting)
• Næstved-Slagelse-Ringsted Sygehus — Næstved, Denmark (Recruiting)
• Odense University Hospital — Odense, Denmark (Recruiting)
• Roskilde Sygehus — Roskilde, Denmark (Recruiting)
• Silkeborg Sygehus — Silkeborg, Denmark (Recruiting)

Study contacts

• Study coordinator: Jens-Ulrik Jensen

Conditions COPD; Inhaled Corticosteroid; Azithromycin; COPD Exacerbation; Pneumonia