Eosinophil-guided Reduction of Inhaled Corticosteroids (NCT04481555) | Clinical Trial Compass
CompletedPhase 4
Eosinophil-guided Reduction of Inhaled Corticosteroids
Denmark444 participantsStarted 2021-06-28
Plain-language summary
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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.