Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.

• Register: EUCTR
• Last refreshed on: 3 September 2018
• Main ID: EUCTR2018-002579-16-SE
• Date of registration: 16/07/2018
• Prospective Registration: Yes
• Primary sponsor: Karolinska University Hospital, Stockholm CF center
• Public title: Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.
• Scientific title: Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study.
• Date of first enrolment: 26/08/2018
• Target sample size: 12
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002579-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Sweden

Contacts

• Name: Lena Hjelte
• Affiliation: Karolinska University Hospital, Stockholm CF center

• Name: Lena Hjelte
• Affiliation: Karolinska University Hospital, Stockholm CF center

Key inclusion & exclusion criteria

Inclusion criteria:
1. Confirmed diagnosis of cystic fibrosis
2. = 18 and < 65 years of age
3. Males and females
4. Clinically stable disease (but different pulmonary status)
5. Willing to participate in the study
6. Willing to use contraceptives
7. Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Previous adverse event on posaconazole
2. Ongoing treatment with posaconazol.
3. Advanced liver disease
4. Prolonged QTc-interval
5. Pregnancy, breastfeeding
6. Ongoing upper or lower respiratory infection requiring antibiotic treatment
7. Ongoing treatment with compounds contraindicated according to FASS
8. Ongoing or previous participation in a clinical pharmaceutical study within 28-days before screening.
9. Investigator assesses that it is not an appropriate study for the patient




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response.
MedDRA version: 20.0 Level: PT Classification code 10074549 Term: Cystic fibrosis respiratory infection suppression System Organ Class: 10042613 - Surgical and medical procedures

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Noxafil®
Pharmaceutical Form: Tablet

Primary Outcome(s)

Main Objective: To study the pharmacokinetic of posaconazole in exhaled breath.

Primary end point(s): Concentration of posaconazol in exhaled breath at different time points.

Secondary Objective: To assess how the concentration of posaconazol in exhaled breath relates to that in serum and saliva.
To assess if there is a correlation between concentration of posaconazol in exhaled breath and pulmonary changes.

Timepoint(s) of evaluation of this end point: 0.5, 1, 1.5, 2, 3, 4, 8, 11, 24, 32, and 48 h after dosing.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 0.5, 1, 1.5, 2, 3, 4, 8, 11, 24, 32, and 48 h after dosing.

Secondary end point(s): Concentration of of posaconazol in serum and saliva.
Pulmonary changes measured by pulmonary function (FEV1) and pulmonary structural changes measured by existing HRCT.

Secondary ID(s)

CF001

Source(s) of Monetary Support

Karolinska University Hospital, Stockholm CF center