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COPD - Eosinophil-guided Reduction of Inhaled Corticosteroids (COPERNICOS)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501035-16-01
Acronym
COPERNICOS
Enrollment
444
Registered
2022-08-23
Start date
2022-08-23
Completion date
2025-12-16
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD)

Brief summary

Number of hospitalization-requiring exacerbations and/or death within 365 days.

Detailed description

Death or “uncontrolled AECOPD tendency” within 365 days., Number of moderate/severe exacerbation within 365 days., Cumulative dose of inhaled corticosteroids within 365 days., Cumulative dose of systemic corticosteroids within 365 days., Change in lung function (ΔFEV1) from baseline to 365 days., Change in blood eosinophils from baseline to 365 days (eosinophilic trajectories)., New diagnosis of diabetes mellitus within 365 days., Change in HbA1c from baseline to 365 days., Antibiotic-requiring infections within 365 days., Difference in respiratory microbiota abundance and diversity at 12 months between treatment arms., Change in COPD-related quality of life (Based on COPD Assessment Test - CAT) from baseline to 365 days., Number who progress to MRC -dyspnea score from < 3 to ≥3 anytime during follow-up (assessed every 3 months)., Number of admission requiring NIV treatment or admissions to intensive care within 365 days., Mortality within 365 days., Difference in immunological profile including cytokines and chemokines in the upper airways from baseline to 12 months between treatment arms, “Days alive and out of hospital" within 365 days after recruitment

Interventions

DRUGAzithromycin "Sandoz"
DRUGPlacebo
DRUGAzithromycin ”Stada”
DRUGAzithromycin ”Jubilant”
DRUGPlacebo corresponding to azithromycin jubilant 250 mg capsule
DRUG-

Sponsors

Gentofte Hospital, Frederiksberg Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of hospitalization-requiring exacerbations and/or death within 365 days.

Secondary

MeasureTime frame
Death or “uncontrolled AECOPD tendency” within 365 days., Number of moderate/severe exacerbation within 365 days., Cumulative dose of inhaled corticosteroids within 365 days., Cumulative dose of systemic corticosteroids within 365 days., Change in lung function (ΔFEV1) from baseline to 365 days., Change in blood eosinophils from baseline to 365 days (eosinophilic trajectories)., New diagnosis of diabetes mellitus within 365 days., Change in HbA1c from baseline to 365 days., Antibiotic-requiring infections within 365 days., Difference in respiratory microbiota abundance and diversity at 12 months between treatment arms., Change in COPD-related quality of life (Based on COPD Assessment Test - CAT) from baseline to 365 days., Number who progress to MRC -dyspnea score from < 3 to ≥3 anytime during follow-up (assessed every 3 months)., Number of admission requiring NIV treatment or admissions to intensive care within 365 days., Mortality within 365 days., Difference in immunological profil

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026