Clinical Research Directory

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 \<80% ref. * 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.