Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FEV1 changes from baseline (3 days before treatment) to Day 14 under ETI
研究概览
简要总结
The goal of this observational study is to provide optimal monitoring and support when initiating ETI treatment in eligible persons with cystic fibrosis (aged 12 y +) and to document on a daily basis, from 72 hours before the start of treatment and then for 14 days i) i) FEV1 changes (home spirometry), ii) ii) respiratory symptoms changes, iii) any possible side effects. Through a dedicated electronic platform, these data will be monitored every day by the medical team, which will be fully available for any questions or concerns patients may have.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis diagnosis
- •At least 12 years old
- •Carrier of at least one copy of F508del mutation
- •Ability to perform reliable and reproducible spirometry
- •Medical and psychological stability
- •written consent
- •owning a smartphone
排除标准
- •Lung transplant
- •FEV1 > 120 % pr (%GLI) at the inclusion test
- •Pulmonary exacerbation
研究组 & 干预措施
CF patients before (3 days) and during (14 days) ETI treatment
Patients over 12 years old and eligible will start ETI treatment ( current standart treatment).
- Morning: Elexacaftor 100 mg, Tezacaftor 50 mg, Ivacaftor 75 mg, 2 tablets
- Evening: Ivacaftor 150 mg
干预措施: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening (Drug)
结局指标
主要结局
FEV1 changes from baseline (3 days before treatment) to Day 14 under ETI
时间窗: 17 days
Daily home spirometry with Spirobank device, between 14H-20H, before nebulization and / or physiotherapy
次要结局
- Respiratory symptoms score changes from baseline (3 days before treatment) to Day 14 under ETI(17 days)
研究者
Lebecque Patrick
Principal investigator, Clinical Professor
CHC Montlegia