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

Inclusion criteria

• Male and female patients ≥40 years of age.
• ≥ 10 pack-years smoking.
• Former smokers (≥6 months).
• post-bronchodilator FEV1/FVC<0.70.
• FEV1 ≥30 (i.e. mild-moderated COPD patients).
• Signed written informed consent form.
• On regular treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage.
• Women of child-bearing potential* must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.
• Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.

Exclusion criteria

• 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.
• Use of ICS in the 3 months prior to the recruitment.
• Participating in another randomized trial.
• Not likely to complete the study.
• Pregnant or breastfeeding females.
• Exacerbations in the previous 8 weeks.
• Primary or secondary immunodeficiency.
• Immunosuppression or regular oral corticosteroid treatment.
• Allergy to IMP's excipients.
• Any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason.