Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

NCT06334575 | Recruiting Phase 4 DMC

• 1 other identifier: 2023-505245-13-00
• Study Type: interventional
• Target: 135
• Locations: 4 countries
• Sites: 6

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Significant molecular changes in COPD stratified by their blood eosinophil counts.

  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.

  8 weeks

Secondary Outcomes (1)

• Significant molecular changes in COPD with different airflow limitation severities.

  8 weeks

Study Arms (2)

ICS treatment

ACTIVE COMPARATOR

Drug: Budesonide

No ICS treatment

NO INTERVENTION

Interventions

Budesonide DRUG

receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks

ICS treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Joyera Rodríguez: lead

Study Sites (6)

Philips University of Marburg

Marburg, Germany

RECRUITING

Academisch Ziekenhuis Groningen

Groningen, Netherlands

RECRUITING

Clínic Barcelona

Barcelona, 08036, Spain

RECRUITING

Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

University of Leicester

Leicester, United Kingdom

NOT YET RECRUITING

Imperial College London

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Rosa Faner

CONTACT

+34932775400; rfaner@recerca.clinic.cat

Maria Joyera

CONTACT

joyera@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

DE (1); ES (2); GB (2); NL (1)