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
- 60
- 试验地点
- 4
- 主要终点
- 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. The changes will be calculated as variations from Visit 2 to Visit 3 (8 weeks).
研究概览
简要总结
To determine the molecular changes associated with the use of ICS in COPD patients with different blood eosinophil counts.
研究设计
- 分配方式
- Randomized
- 主要目的
- Allocation of patients
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
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 <80% ref. (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).
- •Participating in another randomized trial.
- •Not likely to complete the study.
- •Pregnant or breastfeeding females.
- •Exacerbations in the previous 8 weeks.
- •Blood eosinophil count <100 eos/mcL
- •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.
- •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.
结局指标
主要结局
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. The changes will be calculated as variations from Visit 2 to Visit 3 (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. The changes will be calculated as variations from Visit 2 to Visit 3 (8 weeks).
次要结局
- 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. The molecular changes will be calculated as variations from Visit 2 to Visit 3.
研究者
Rosa Faner
Scientific
Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer