Chronic Obstructive Pulmonary DiseasePhase 43TR-ICS-COPDNCT06334575
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
A Phase 4 study testing Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Maria Joyera Rodríguez at 6 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 12 Feb 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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.
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- 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.
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Maria Joyera contact
6 sites in 4 countries
Spain2 sites, 2 recruiting
- Recruiting
Clínic Barcelona
Barcelona, 08036
Alvar Agustí
- Recruiting
Son Espases
Palma de Mallorca, 07120
Francisco de Borja Cosio
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
University of Leicester
Leicester
Christopher Brightling
- Not yet recruiting
Imperial College London
London
Lydia J Finney
Germany1 site, 1 recruiting
- Recruiting
Philips University of Marburg
Marburg
Peter Alter
Netherlands1 site, 1 recruiting
- Recruiting
Academisch Ziekenhuis Groningen
Groningen
Marteen van den Berge
About this study
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
- Being tested
- Budesonide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| ICS treatment | Active comparator | Not described Receives: Drug: Budesonide |
| No ICS treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start12 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Joyera Rodríguez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Joyera Rodríguez, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334575
- Sponsor's protocol ID
- 2023-505245-13-00
- Other IDs
- 2023
- Acronym
- 3TR-ICS-COPD
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
- ClinicalTrials.gov ID
- NCT06334575
- Acronym / sponsor ID
- 3TR-ICS-COPD / 2023-505245-13-00
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Maria Joyera RodríguezUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICS treatment | Active comparator | Drug: Budesonide |
| No ICS treatment | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonidereceive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks | Drug | ICS treatment |
Primary outcome
Significant molecular changes in COPD stratified by their blood eosinophil counts.
Time frame: 8 weeks
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.
1 secondary outcome
Significant molecular changes in COPD with different airflow limitation severities.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Joyera contact
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Maria Joyera Rodríguez at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, United Kingdom, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa Faner (+34932775400, rfaner@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant molecular changes in COPD stratified by their blood eosinophil counts. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.