Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

ConditionChronic Obstructive Pulmonary Disease

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age40+

SponsorMaria Joyera Rodríguez

About this trial

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

Eligibility criteria

Qualifiers

Male and female patients ≥40 years of age.

≥ 10 pack-years smoking.

Former smokers (≥6 months).

post-bronchodilator FEV1/FVC<0.70.

Disqualifiers

Presence of other respiratory disorders, (i.e. current physician diagnosis of asthma, early life history of asthma (<21 years) a previous clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary eosinophilia).

Long-term oxygen therapy or non-invasive mechanical ventilation at home.

Current smokers.

Active cancer.