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Taking peoplePhase 4

Studies biological markers of response to inhaled steroid in COPD patients

Tests budesonide in former smokers with COPD, stratified by eosinophil levels.

Key facts

Who runs it
Maria Joyera Rodríguez
Where
Leicester and London, United KingdomSee the 2 sitesAlso in 3 other countries, 4 sites
Trial code
Registry title
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Status
Recruiting
Phase
Phase 4
People taking part
135 people, planned
Started
12 Feb 2025
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Budesonide
Record updated
20 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for stable former smokers aged 40 or older with mild to moderate COPD who already use two long-acting bronchodilators and are not using inhaled corticosteroids.

Age
40 years or older
Sex
All sexes can join.
Disease stage
Mild to moderate COPD, with post-bronchodilator FEV1/FVC below 0.70 and FEV1 of 30 or more. No flare-ups in the previous 8 weeks.
Earlier treatment
Must have used two long-acting bronchodilators (LABA+LAMA) regularly for at least 8 weeks. Must not have used inhaled corticosteroids (ICS) in the last 3 months.

Main reasons for not taking part

  • Other lung diseases such as asthma, bronchiectasis or interstitial lung disease
  • Current smokers
  • Active cancer
  • Long-term oxygen therapy or home ventilation
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Use of ICS in the 3 months prior to the recruitment
  • Exacerbations in the previous 8 weeks
  • Immunosuppression or regular oral corticosteroid treatment
  • Active cancer
  • Allergy to IMP's excipients
  • Current smokers
  • Participating in another randomized trial
  • Not likely to complete the study
  • Pregnant or breastfeeding females
  • Primary or secondary immunodeficiency
  • 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 in United Kingdom

Also in 3 other countries, 4 sites

  • University of LeicesterLeicester, United KingdomContact: Christopher BrightlingNot yet recruiting
  • Imperial College LondonLondon, United KingdomContact: Lydia J FinneyNot yet recruiting

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • ICS treatmentExisting treatment, for comparison

    Treatment: Budesonide

  • No ICS treatmentNo study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Plain-language title
Studies biological markers of response to inhaled steroid in COPD patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 July 2026