Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Significant molecular changes in COPD stratified by their blood eosinophil counts.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥40 years of age.
- •≥ 10 pack-years smoking.
- •Former smokers (≥6 months).
- •post-bronchodilator FEV1/FVC<0.
- •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.
排除标准
- •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.
研究组 & 干预措施
ICS treatment
干预措施: Budesonide (Drug)
No ICS treatment
结局指标
主要结局
Significant molecular changes in COPD stratified by their blood eosinophil counts.
时间窗: 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.
次要结局
- Significant molecular changes in COPD with different airflow limitation severities.(8 weeks)
研究者
Maria Joyera Rodríguez
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica