Chronic Obstructive Pulmonary Disease
Conditions
Brief 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 (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
Interventions
DRUGBudesonide
receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks
Sponsors
Maria Joyera Rodríguez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant molecular changes in COPD stratified by their blood eosinophil counts. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant molecular changes in COPD with different airflow limitation severities. | 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 with different airflow limitation severities. |
Countries
Germany, Netherlands, Spain, United Kingdom
Contacts
CONTACTRosa Faner
CONTACTMaria Joyera
Outcome results
None listed