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Eosinophil-guided Reduction of Inhaled Corticosteroids

Eosinophil-guided Reduction of Inhaled Corticosteroids

Recruiting
40 years and older
All
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

  • COPD (verified by a specialist in respiratory medicine + spirometry)
  • GOLD risk class C/D 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%.
  • Must receive at least during last 4 weeks: 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 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.

Study details
    COPD
    Inhaled Corticosteroid
    Azithromycin
    COPD Exacerbation
    Pneumonia

NCT04481555

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

27 January 2024

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