The role of innate lymphoid cells in COPD and rhinovirus-induced COPD exacerbations - RILCO

Academisch Medisch Centrum0 个研究点目标入组 65 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•For rhinovirus challenges, patients
•* non-smoking, or ex-smoking (*1 years ago), *10 pack years; GOLD stage II (post bronchodilator FEV1 <80% predicted and FEV1/FVC <70%)
•* Allowed COPD specific medication: LABA and LAMA medication will be allowed, but no ICS
•* Have no history of bronchiectasis, lung cancer or other significant respiratory disease.
•* Be stable on COPD medication, no exacerbation or changes in COPD medication in the past 6 weeks. ;The age- and smoking history-matched controls will be extensively characterized with respect to lung function, medication and medical history. They have to:
•* Be non-smoking, or ex-smoking (*1 years ago)
•* Have no respiratory diagnosis of asthma or COPD
•* Have no history of bronchiectasis, lung cancer or other significant respiratory disease.;For the COPD patients not challenged with rhinovirus:
•* non-smoking, or ex-smoking (*2 years ago), GOLD I, II, IV
•* no history of bronchiectasis, lung cancer or other significant respiratory disease;Non-COPD control group, not challenged with rhinovirus:
•* Be non-smoking, or ex-smoking (*2 years ago), apart from those belonging to the controls who smoke
•* Have no respiratory diagnosis of asthma or COPD

•For rhinovirus challenges,
•* Women who are pregnant, lactating or have a positive urine pregnancy test at visit 1
•* RV16 titre > 1:6 in serum, measured at visit 1
•* Has had any acute illness, including a common cold, within 4 weeks prior to visit 1
•* Close contact with young children (< 2 years)
•* Has donated blood or has had a blood loss of more than 450 mL within 60 days prior to screening visit 1 or plans to donate blood during the study;For the patients not challenged with rhinovirus:
•* Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient

发起方