COPD - Eosinophil-guided Reduction of Inhaled Corticosteroids (COPERNICOS)
- Conditions
- Chronic obstructive pulmonary disease (COPD)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2022-501035-16-01
- Lead Sponsor
- Gentofte Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 444
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.
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 participte 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method