NCT06334575 Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
| NCT ID | NCT06334575 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Maria Joyera Rodríguez |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 135 participants in total. It began in 2025-02-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06334575 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06334575 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06334575 currently recruiting?
Yes, NCT06334575 is actively recruiting participants. Contact the research team at rfaner@recerca.clinic.cat for enrollment information.
Where is the NCT06334575 trial being conducted?
This trial is being conducted at Marburg, Germany, Groningen, Netherlands, Barcelona, Spain, Palma de Mallorca, Spain and 2 additional locations.
Who is sponsoring the NCT06334575 clinical trial?
NCT06334575 is sponsored by Maria Joyera Rodríguez. The trial plans to enroll 135 participants.