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Looking for participantsPhase4

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

Sponsor: Maria Joyera Rodríguez

NCT ID: NCT06334575

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Budesonide (drug)
How long the study runs
Study runs about 34 months (dates as stated)
About the drug or intervention
Budesonide — drug: receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at people with chronic obstructive pulmonary disease (COPD) to find signs in the body that may show who responds well to inhaled corticosteroids (ICS), a type of inhaled medicine. The study groups patients by their eosinophil levels (a type of white blood cell). The sponsor is Maria Joyera Rodríguez.

Who can take part

  • Men and women aged 40 or over
  • Smoked at least 10 pack-years and gave up smoking at least 6 months ago
  • Breathing tests show COPD that is mild to moderate
  • Signed a consent form
  • Already using two regular inhaled medicines (long-acting bronchodilators, called LABA and LAMA) for at least 8 weeks
  • Women who can become pregnant must have a negative pregnancy test and use highly effective contraception (coil, sterilisation, vasectomised partner, or abstinence; hormonal contraception is avoided)

Who may not be able to

  • Other breathing problems, such as asthma, bronchiectasis, interstitial lung disease, or high eosinophils in the lungs
  • Use long-term oxygen or breathing machines at home
  • Currently smoke
  • Have active cancer
  • Used ICS medicine in the past 3 months
  • Taking part in another randomised trial
  • Unlikely to finish the study
  • Pregnant or breastfeeding
  • Had a flare-up of COPD in the past 8 weeks
  • Weakened immune system, immunosuppression, or regular steroid tablets
  • Allergy to ingredients of the study medicine
  • Any other reason the study doctor thinks makes participation unsuitable

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Number of visits and study length: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
135
Started
2025-02-12
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease
  • • Phase4 - 135 participants
  • • 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)

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with chronic obstructive pulmonary disease

Where?

  • • Leicester - University of Leicester
  • • London - Imperial College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Chronic Obstructive Pulmonary Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ a negative pregnancy test in serum or urine

What the study is looking for

  • ✓Male and female patients ≥40 years of age.
  • ✓≥ 10 pack-years smoking.
  • ✓Former smokers (≥6 months).
  • ✓post-bronchodilator FEV1/FVC\<0.70.
  • ✓FEV1 ≥30 (i.e. mild-moderated COPD patients).

Who cannot take part

  • ✗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 randomly assigned trial.
See the full 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 (i.e. mild-moderated COPD patients). * 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 Is This Study? (2 UK sites)

University of Leicester

Leicester, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Imperial College London

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

How to Get in Touch

Rosa Faner

Sponsor contact

CONTACT

+34932775400 rfaner@recerca.clinic.cat

Maria Joyera

Sponsor contact

CONTACT

joyera@recerca.clinic.cat
Data sourced from ClinicalTrials.gov · Last verified: 2026-07