Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD)

COPD - Eosinophil-guided Reduction of Inhaled COrticoSteroids (COPERnICOS) - COPERNICOS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003014-12-DK

Enrollment

444

Registered

2020-07-09

Start date

2021-03-19

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

Clinicaltrial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

Interventions

Trade Name: Azithromycin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Azithromycin Other descriptive name: AZITHROMYCIN Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

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=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: • Known asthma • Male 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: ICS: •Whether a strategy of eosinophil-guided administration of inhaled corticosteroids in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) can lead to non-inferior treatment responses to triple therapy (ICS/LABA/LAMA). •Whether side effects and exposure to ICS can be reduced with the eosinophil-guided administration of inhaled corticosteroids. Azithromycin: •Whether the use of prophylactic low dose Azithromycin in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) can improve “time alive and out of hospital” while reducing moderate and severe exacerbations. ;Secondary Objective: ICS: •Whether a strategy of eosinophil-guided administration of inhaled corticosteroids in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) leads to a change in the respiratory microbiota abundance and diversity in comparison to continuous triple therapy (ICS/LABA/LAMA). Azithromycin: •Whether prophylactic low dose Azithromycin in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) leads to changes in the respiratory microbiota abundance and diversity. ;Primary end point(s): ICS and Azithromycin: •“Days alive and out of hospital within 365 days after recruitment” (continuous data: analysis with T-test) •Number of hospitalization-requiring exacerbations and/or death within 365 days (continuous data: analysis with chi squared test) ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: ICS: •Whether a strategy of eosinophil-guided administration of inhaled corticosteroids in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) can lead to non-inferior treatment responses to triple therapy (ICS/LABA/LAMA). •Whether side effects and exposure to ICS can be reduced with the eosinophil-guided administration of inhaled corticosteroids. Azithromycin: •Whether the use of prophylactic low dose Azithromycin in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) can improve “time alive and out of hospital” while reducing moderate and severe exacerbations. ;Secondary Objective: ICS: •Whether a strategy of eosinophil-guided administration of inhaled corticosteroids in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) leads to a change in the respiratory microbiota abundance and diversity in comparison to continuous triple therapy (ICS/LABA/LAMA). Azithromycin: •Whether prophylactic low dose Azithromycin in COPD patients (GOLD risk class C/D and/or FEV1 < 30%) leads to changes in the respiratory microbiota abundance and diversity. ;Primary end point(s): ICS and Azithromycin: •“Days alive and out of hospital within 365 days after recruitment” (continuous data: analysis with T-test) •Number of hospitalization-requiring exacerbations and/or death within 365 days (continuous data: analysis with chi squared test) ;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end points ICS and Azithromycin: • 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 (?FEV1) from baseline to 365 days Explanatory end points ICS: • 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 ICS and Azithromycin: • Difference in respiratory microbiota abundance and diversity at 6 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 ;Timepoint(s) of evaluation of this end point: At baseline and 12 months, except blood samples and MRC every 3 month (baseline, 3, 6, 9 and 12 months)	—

Measure

Time frame

Secondary end point(s): Secondary end points ICS and Azithromycin: • 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 (?FEV1) from baseline to 365 days Explanatory end points ICS: • 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 ICS and Azithromycin: • Difference in respiratory microbiota abundance and diversity at 6 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 ;Timepoint(s) of evaluation of this end point: At baseline and 12 months, except blood samples and MRC every 3 month (baseline, 3, 6, 9 and 12 months)

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Countries

Denmark

Contacts

Public Contactwww.coptrin.dk

COP:TRIN

jens.ulrik.jensen@regionh.dk+4528938168

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026