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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 3TR-ICS-COPD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334575
• Other study ID #: 2023-505245-13-00
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Rosa Faner
• Phone: +34932775400
• Email: rfaner[@]recerca.clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Germany	Philips University of Marburg	Marburg
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Spain	Clínic Barcelona	Barcelona
Spain	Son Espases	Palma De Mallorca
United Kingdom	University of Leicester	Leicester
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Maria Joyera Rodríguez

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Significant molecular changes in COPD with different airflow limitation severities.	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 with different airflow limitation severities.	8 weeks