Identifying molecular responses to ICS treatment in COPD patients based on eosinophil levels
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
This study is testing how well a medication called Budesonide works for former smokers with COPD based on their eosinophil levels and the bacteria in their lungs.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Locations | 6 sites (Marburg and 5 other locations) |
| Trial ID | NCT06334575 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to recruit clinically stable former smokers with Chronic Obstructive Pulmonary Disease (COPD) who have been on dual long-acting bronchodilator treatment for at least 8 weeks. Participants will be randomized to receive Budesonide, and the study will focus on identifying molecular signatures related to the response to inhaled corticosteroid (ICS) treatment, specifically stratified by eosinophil levels and the influence of the pulmonary microbiome. The study will involve multiple international centers to gather diverse data on patient responses.
Who should consider this trial
Good fit: Ideal candidates are former smokers aged 40 and above with stable COPD who have been using dual long-acting bronchodilators for at least 8 weeks.
Not a fit: Patients with other respiratory disorders or those currently receiving ICS treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for COPD patients, improving their management and outcomes.
How similar studies have performed: Other studies have explored molecular responses in COPD, but this specific stratification by eosinophil levels and microbiome influence is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Marburg and 5 other locations
- Philips University of Marburg — Marburg, Germany (Recruiting)
- Academisch Ziekenhuis Groningen — Groningen, Netherlands (Recruiting)
- Clínic Barcelona — Barcelona, Spain (Recruiting)
- Son Espases — Palma de Mallorca, Spain (Recruiting)
- University of Leicester — Leicester, United Kingdom (Not_yet_recruiting)
- Imperial College London — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Rosa Faner
- Email: rfaner@recerca.clinic.cat
- Phone: +34932775400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.