Clinical trial NCT06334575: Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Official title: Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Primary outcomes:
measure: Significant molecular changes in COPD stratified by their blood eosinophil counts.
timeFrame: 8 weeks
Secondary outcomes:
measure: Significant molecular changes in COPD with different airflow limitation severities.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philips University of Marburg
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Barcelona
country: Spain
facility: Clínic Barcelona
city: Palma De Mallorca
country: Spain
facility: Son Espases
city: Leicester
country: United Kingdom
facility: University of Leicester
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
References: