Functional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del.

Antwerp University Hospital0 个研究点目标入组 20 人开始时间: 2018年5月8日最近更新: 2020年4月6日

适应症

试验速览

暂无简介。

•1. Documented diagnosis of CF (homozygous for the F508del mutation must be present, this should be documented in the medical history).
•2. Age = 12 years
•3. FEV1 ³ 50%
•4. Signed informed consent. If patient is a minor, parents/guardians must give written informed consent
•5. Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit 1
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. FEV1 < 50%
•2. Anticipated requirement for hospitalization within the next three weeks
•3. History of pneumothorax within the past 6 months prior to Visit 1
•4. History of haemoptysis requiring embolization within the past 12 months prior to Visit 1
•5. Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
•6. Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1
•7. Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA)
•8. Pregnant or lactating female
•9. Posttransplant patients
•10. Patients with severe hepatic impairment

发起方