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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003014-12 | EudraCT Number |
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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.
Inhaled corticosteroid (ICS) treatment is recommended by Global Initiative for Obstructive Lung Disease (GOLD) for patients with frequent and/or servere exacerbations and blood eosinophils > 0.3 x 10^9 cells/L and in those with ≥ 0,1 x 109 cells blood-eosinophils and recurrent exacerbations while on bronchodilators. ICS treatment, however, is associated with side effects such as diabetes, osteoporosis and pneumonia which is costly for both patients and society. By studying the effects of a personalized, eoseosinophil-guided approach to direct ICS in COPD patients with frequent AECOPDs through a randomized clinical trial this study will examine the possibilities of reducing ICS overtreatment and thus ICS-related adverse events.
Long term ICS treatment is known for affecting the bacterial load in stable COPD patients. Azithromycin exerts multiple effects on the structure and composition of the lower airway microbiota and has anti-inflammatory effects. This study will, moreover, investigate whether an oral low-dose prophylactic treatment with Azithromycin 250 mg three times weekly can reduce the number of moderate-severe AECOPD and improves time alive and out of hospital.
This study is a randomized, double-blinded, multicentre, four-arm intervention clinical trial and is conducted based on the principles of good clinical practise (GCP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eosinophil_"Control"/Azithro_"Control" | No Intervention |
| |
| Eosinophil_"Active"/Azithro_"Control": | Experimental | a. Azithromycin: placebo b. ICS: All patients will receive LABA/LAMA medication. The ICS medication will be switched on/off according to the most recent blood eosinophil count (at inclusion + every 3 months): i. If blood eosinophil ≥ 300 cells/μL, ICS in usual dose next 3 months. Blood eosinophils are measured every 3 months. ii. If blood eosinophil <300 cells/μL, ICS is discontinued. |
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| Eosinophil_"Control"/Azithro_"Active" group | Experimental | Azithromycin: 250 mg azithromycin three times weekly. b. ICS: The patients are given the usual LAMA/LABA/ICS product in the usual dose, where the medical treatment for severe COPD is unchanged throughout the entire project period |
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| Eosinophil_"Active"/Azithro_"Active": | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Prophylactic azithromycin treatment 250 mg three times weekly vs placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbations, hospital and death | Number of hospitalization-requiring exacerbations within 12 months and/or death within 365 days | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Days alive, out of hospital | Days alive and out of hospital within 365 days after recruitment | 365 days |
| Deaths, uncontrolled AECOPD | Death or uncontrolled AECOPD tendency within 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Hvidovre Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40898355 | Derived | Ronn C, Bonnesen B, Alispahic IA, Tonnesen LL, Kjaergaard JL, Moberg M, Ulrik CS, Harboe ZB, Browatzki A, Jensen TT, Meyer CN, Bodtger U, Bendstrup E, Johansson SL, Kaiser DU, Hyldgaard C, Vestbo J, Sivapalan P, Jensen JS. Study protocol: COPD-eosinophil-guided reduction of inhaled corticosteroids (COPERNICOS) : A randomized, double-blinded, multicenter, four-arm intervention clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic low dose Azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD). Trials. 2025 Sep 2;26(1):335. doi: 10.1186/s13063-025-09032-0. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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4-arm facultative designed, randomized controlled, multicenter, parallel group, double-blinded (azithromycin), non-inferiority intervention study in patients with severe and very severe COPD study.
Participants will be randomly allocated to one of four treatment groups.
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| ICS | Drug | All patients will receive LABA/LAMA medication. The ICS medication will be switched on/off according to the most recent blood eosinophil count (at inclusion + every 3 months) vs continued LABA/LAMA/ICS treatment |
|
| 365 days |
| Number of exacerbations | Number of moderate/severe exacerbation within 365 days | 365 days |
| Cumulative ICS dose | Cumulative dose of inhaled corticosteroids within 365 days | 365 days |
| Cumulative OCS dose | Cumulative dose of systemic corticosteroids within 365 days | 365 days |
| Change in FEV1 | Change in lung function (ΔFEV1) from baseline to 365 days | 365 days |
| Change in blood eosinophils | Change in blood eosinophils from baseline to 365 days (eosinophilic trajectories) | 365 days |
| Diabetes mellitus | New diagnosis of diabetes mellitus within 365 days | 365 days |
| Change in HbA1c | Change in HbA1c from baseline to 365 days | 365 days |
| Number of antibiotic requiring infections | Antibiotic-requiring infections within 365 days | 365 days |
| Microbiota, abundance and diversity | Difference in respiratory microbiota abundance and diversity from baseline to 12 months between treatment arms | 365 days |
| Microbiota, immunological profile | Difference in immunological profile including cytokines and chemokines in the upper airways from baseline to 12 months between treatment arms | 365 days |
| Change in CAT score | Change in COPD-related quality of life (Based on COPD Assessment Test - CAT) from baseline to 365 days | 365 days |
| Change in MRC dyspnoea score | Number who progress to MRC -dyspnea score from < 3 to ≥3 anytime during follow-up (assessed every 3 months). | 365 days |
| Number of non-invasive ventilation (NIV) or intensive care admissions or death | Number of admission requiring non-invasive ventilation (NIV) treatment or admissions to intensive care within 365 days | 365 days |
| Mortality | Mortality within 365 days | 365 days |
| Copenhagen |
| Denmark |
| Sydvestjysk Sygehus Esbjerg | Esbjerg | Denmark |
| Gentofte Hospital | Hellerup | Denmark |
| Nordsjællands Hospital | Hillerød | Denmark |
| Næstved-Slagelse-Ringsted Sygehus | Næstved | Denmark |
| Odense University Hospital | Odense | Denmark |
| Roskilde Sygehus | Roskilde | Denmark |
| Silkeborg Sygehus | Silkeborg | Denmark |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| Organic Chemicals |