Budesonide for Chronic obstructive pulmonary disease (COPD)

Stratification factors

• blood eosinophil levels (<100 cells/mcL; 100-300 cells/mcL; >300 cells/mcL)

Inclusion criteria

• {"criterion_text":"- Male and female patients ≥40 years of age.\n- ≥ 10 pack-years smoking.\n- Former smokers (≥6 months).\n- post-bronchodilator FEV1/FVC<0.70.\n- FEV1 ≥30 (i.e. mild-moderated COPD patients).\n- Signed written informed consent form.\n- On regular treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage.\n- 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.\n- Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function."}

Exclusion criteria

• {"criterion_text":"- 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).\n- Primary or secondary immunodeficiency.\n- Immunosuppression or regular oral corticosteroid treatment.\n- Allergy to IMP’s excipients.\n- Any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason.\n- Long-term oxygen therapy or non-invasive mechanical ventilation at home.\n- Current smokers.\n- Active cancer.\n- Use of ICS in the 3 months prior to the recruitment.\n- Participating in another randomized trial.\n- Not likely to complete the study.\n- Pregnant or breastfeeding females.\n- Exacerbations in the previous 8 weeks.\n- Blood eosinophil count <100 eos/mcL"}

Primary endpoints

• {"endpoint_text":"- Significant molecular changes (p<0.05, and/or FDR<0.05) (e.g. microbiome and/or transcriptome and/or proteins and/or epigenetics) in sputum, nasal and oropharyngeal swabs, urine and/or blood associated with ICS treatment vs. no ICS treatment (usual care), in COPD stratified by their blood eosinophil counts. The changes will be calculated as variations from Visit 2 to Visit 3 (8 weeks).","definition_or_measurement_approach":"Measured as significant molecular changes (p<0.05 and/or FDR<0.05) in samples (sputum, nasal and oropharyngeal swabs, urine and/or blood) associated with ICS treatment versus no ICS (usual care); changes calculated as variations from Visit 2 to Visit 3 (8 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Significant molecular changes (p<0.05, and/or FDR<0.05) (e.g. microbiome and/or transcriptome and/or proteins and/or epigenetics) in sputum, nasal and oropharyngeal swabs, urine and/or blood associated with ICS treatment vs. no ICS treatment (usual care), in COPD with different airflow limitation severities. The molecular changes will be calculated as variations from Visit 2 to Visit 3.","definition_or_measurement_approach":"Measured as significant molecular changes (p<0.05 and/or FDR<0.05) in listed samples associated with ICS treatment versus no ICS; changes calculated as variations from Visit 2 to Visit 3."}

Germany

Latest Decision Or Authorization Date

18-07-2024

Number Of Sites

1

Number Of Participants

15

Spain

Latest Decision Or Authorization Date

16-07-2024

Number Of Sites

2

Number Of Participants

35

Netherlands

Latest Decision Or Authorization Date

17-07-2024

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

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

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain