Eosinophil-guided Reduction of Inhaled Corticosteroids

Launched by CHRONIC OBSTRUCTIVE PULMONARY DISEASE TRIAL NETWORK, DENMARK · Jul 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how reducing the use of inhaled corticosteroids (ICS) can help patients with severe chronic obstructive pulmonary disease (COPD). The researchers want to see if adjusting the ICS treatment based on eosinophil levels—certain white blood cells that can indicate inflammation—can improve patients' health. Participants in the trial will also receive azithromycin, an antibiotic, to see if it helps prevent lung infections.

To be eligible for this study, you must have a confirmed diagnosis of COPD and have experienced at least two flare-ups (worsening of symptoms) in the past two years. Additionally, you should have been on specific medications for your COPD for at least four weeks before joining the trial. This study is open to all adults, but there are some criteria that could exclude individuals, such as having asthma or certain medical conditions. If you participate, you will be closely monitored and may have the chance to adjust your medication in a way that could potentially improve your COPD management.

Gender

ALL

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.