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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
135
receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks
Philips University of Marburg
Marburg, Germany
RECRUITINGAcademisch Ziekenhuis Groningen
Groningen, Netherlands
RECRUITINGClínic Barcelona
Barcelona, Spain
RECRUITINGSon Espases
Palma de Mallorca, Spain
RECRUITINGUniversity of Leicester
Leicester, United Kingdom
NOT_YET_RECRUITINGImperial College London
London, United Kingdom
NOT_YET_RECRUITINGSignificant 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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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