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.

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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002579-16-SE

Enrollment

Registered

2018-07-16

Start date

2018-08-26

Completion date

Unknown

Last updated

2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

Trade Name: Noxafil® Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of cystic fibrosis 2. = 18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the pharmacokinetic of posaconazole in exhaled breath.;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. ;Primary end point(s): Concentration of posaconazol in exhaled breath at different time points. ;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.	—

Measure

Time frame

Main Objective: To study the pharmacokinetic of posaconazole in exhaled breath.;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. ;Primary end point(s): Concentration of posaconazol in exhaled breath at different time points. ;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

Measure	Time frame
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. ;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.	—

Countries

Sweden

Contacts

Public ContactLena Hjelte

Karolinska University Hospital, Stockholm CF center

lena.hjelte@sll.se+4672560 36 32

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026