Molecular signatures associated with response to ICS treatment in patients with COPD stratified by eosinophil levels
Key facts
- Where
- Barcelona és Palma, SpanyolországSee the 2 sites
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- University Hospital Son EspasesPalma, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Trial code
- EU 2023-505245-13-00
- Record updated
- 2026. január 11.
- Original description
To determine the molecular changes associated with the use of ICS in COPD patients with different blood eosinophil counts.Read full original descriptionShow less
To determine the molecular changes associated with the use of ICS in COPD patients with different blood eosinophil counts.
Inclusion: 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: 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); Exacerbations in the previous 8 weeks; Immunosuppression or regular oral corticosteroid treatment; Long-term oxygen therapy or non-invasive mechanical ventilation at home; Use of ICS in the 3 months prior to the recruitment; Allergy to IMP’s excipients; Active cancer; Blood eosinophil count <100 eos/mcL; Participating in another randomized trial; Not likely to complete the study; Pregnant or breastfeeding females; Primary or secondary immunodeficiency; Any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason; Current smokers.