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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (2 UK sites)
University of Leicester
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Imperial College London
London, United Kingdom
How to Get in Touch
Rosa Faner
Sponsor contactCONTACT
Maria Joyera
Sponsor contactCONTACT
