Cystic Fibrosis
Conditions
Interventions
Trade Name: Ivacaftor/Kalydeco
Pharmaceutical Form: Film-coated tablet
Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: curcum
Sponsors
University Medical Centre Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. CFTR genotype compound/ S1251N 2. CFTR measurement available in intestinal biopsies 3. Males and females, aged 6 years or older on the date of informed consent or, where appropriate, date of assent 4. Signed informed consent form (IC), and where appropriate, signed assent form Are the trial subjects under 18? yes Number of subjects for this age range: 7 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe acute exacerbation or pulmonary infection during last four weeks (needing intravenous treatment); 2. Use of curcumin and or genistein at start or within four weeks prior to start of the study; 3. Participation in another drug-investigating clinical study at the start or within four weeks prior to the start; 4. Inability to follow instructions of the investigator; 5. In case of (potential) pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Curcumin and genistein might be a cheap alternative for treating patients with a class III gating mutation Main objective of the trial is to investigate the clinical response on treatment with curcumin and genistein in CF-patients with a class III S1251N mutation, relative to the clinical response on Ivacaftor therapy. ;Secondary Objective: 1.To evaluate the correlations between individual curcumin+genistein and Ivacaftor induced CFTR function in vitro (organoid-based measurements) and the in vivo treatment effect (lungfunction, airway resistance and SCC); 2.To assess whether the dosage of curcumin+genistein and Ivacaftor used in the clinical study is sufficient to stimulate CFTR function. We will evaluate the CFTR stimulating ability of the concentration of curcumin+genistein and Ivacaftor in the patient’s blood samples. We will examine this by in vitro testing (in the organoid model), evaluating the CFTR stimulating ability of the concentration of curcumin+genistein and Ivacaftor in the patient’s blood samples. ;Primary end point(s): Difference in lung function (%FEV1), airway resistance (Rint and bodybox) and sweat choline concentration: ;Timepoint(s) of evaluation of this end point: - before and after receiving curcumin+genistein - before and after treatment with Ivacaftor | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Correlation between individual curcumin+genistein and Ivacaftor induced CFTR function in vitro (organoid-based measurements) and in vivo effect (lung function, SCC); 2. The CFTR stimulating ability of the concentration of curcumin+genistein and Ivacaftor in the patient’s blood samples, examined by in vitro testing (in the organoid model). 3. Difference in BMI; 4. Difference in quality of life (measured with CFQ-questionnaire) . ;Timepoint(s) of evaluation of this end point: Before and after the use of curcumin+genistein and Ivacaftor. The in vitro measurements of the first end point will be determined in the laboratory at any time during the trial. | — |
Countries
Netherlands
Contacts
Public ContactGitte Berkers
University Medical Center Utrecht
Outcome results
None listed