Cystic fibrosis Mucoviscoidosis
Conditions
Interventions
The sole intervention in this study is a single venous puncture for the
collection of 5 ml of blood.
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1.Cystic fibrosis based on DBC code ( specialisme: 0322 ; Diagnose: 1403) 2.Use of Kaftrio tablets with dosage of 75/5-/100mg and ATC code: R07AX32 3.Use of standard dose of ETI (2 tablets in the morning) and Ivacaftor (1 tablet in the evening). 4.Availability of a baseline and on ETI treatment sweat chloride value 5.A homozygous F508del mutation in the CFTR gene 6.A stable clinical condition defined as no pulmonary exacerbation in a period of 4 weeks before study visit
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Solid organ transplantation 2. The use of concomitant medications with CYP3A4 interactions during the period of determining the trough concentration of ETI 3. Pregnancy 4. Liver cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will involve the determination of the trough concentration (Ctrough) of ETI in all 20 collected blood samples for statistical analysis. We will compare Ctrough of the group with the highest absolute sweat chloride decrease to C trough levels of the group with the lowest absolute sweat chloride decrease. Since our study group is small, we will use a non-parametric, Mann-whitney u test to compare the Ctrough of ETI in both groups. | — |
Countries
Netherlands
Outcome results
None listed