Molecular signatures associated with response to ICS treatment in patients with COPD stratified by eosinophil levels

Phase 1

Conditions: Chronic obstructive pulmonary disease (COPD)
MedDRA version: 21.1Level: LLTClassification code: 10010952Term: COPD Class: 10038738
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: CTIS2023-505245-13-00

Lead Sponsor: Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

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. (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)., Participating in another randomized trial., Not likely to complete the study., Pregnant or breastfeeding females., Exacerbations in the previous 8 weeks., Blood eosinophil count <100 eos/mcL, 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., 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.