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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ICS treatment

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

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

No ICS treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Budesonide

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No