Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 6
- Primary Endpoint
- Significant molecular changes in COPD stratified by their blood eosinophil counts.
Study Overview
Brief Summary
The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or > 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients ≥40 years of age.
- •≥ 10 pack-years smoking.
- •Former smokers (≥6 months).
- •post-bronchodilator FEV1/FVC<0.
- •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.
Arms & Interventions
ICS treatment
Intervention: Budesonide (Drug)
No ICS treatment
Outcomes
Primary Outcomes
Significant molecular changes in COPD stratified by their blood eosinophil counts.
Time Frame: 8 weeks
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.
Secondary Outcomes
- Significant molecular changes in COPD with different airflow limitation severities.(8 weeks)
Investigators
Maria Joyera Rodríguez
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica