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The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or > 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICS treatment | Active Comparator |
| |
| No ICS treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Significant molecular changes in COPD stratified by their blood eosinophil counts. | Significant molecular changes (p<0.05, and/or FDR<0.05) (e.g. microbiome and/or transcriptome and/or proteins and/or epigenetics) in sputum, nasal and oropharyngeal swabs, urine and/or blood associated with ICS treatment vs. no ICS treatment (usual care), in COPD stratified by their blood eosinophil counts. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Significant molecular changes in COPD with different airflow limitation severities. | Significant molecular changes (p<0.05, and/or FDR<0.05) (e.g. microbiome and/or transcriptome and/or proteins and/or epigenetics) in sputum, nasal and oropharyngeal swabs, urine and/or blood associated with ICS treatment vs. no ICS treatment (usual care), in COPD with different airflow limitation severities. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Faner | Contact | +34932775400 | rfaner@recerca.clinic.cat | |
| Maria Joyera | Contact | joyera@recerca.clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips University of Marburg | Recruiting | Marburg | Germany |
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| Academisch Ziekenhuis Groningen | Recruiting | Groningen | Netherlands |
|
| Clínic Barcelona | Recruiting | Barcelona | 08036 | Spain |
|
| Son Espases | Recruiting | Palma de Mallorca | 07120 | Spain |
|
| University of Leicester | Not yet recruiting | Leicester | United Kingdom |
|
| Imperial College London | Not yet recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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