Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study

Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004295-35-AT

Enrollment

Registered

2014-04-02

Start date

2014-04-30

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

Chronic lung P. Aeruginosa Infection MedDRA version: 16.1 Level: PT Classification code 10061229 Term: Lung infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Verneble

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients suffering from cystic fibrosis - age >= 12 years - chronic P. aeruginosa lung infection - clinically stable at outpatient visit - FEV1 >= 75 % of predicted previous antibiotic aerosol treatment Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients with CF related liver disease or renal disease - pregnant and nursing women

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the changes in lung clearance index before and after each 4-week-on/4-week-off cycle of different inhaled antibiotics;Secondary Objective: not applicable;Primary end point(s): relative change in LCI after treatment with AZLI and after standard therapy;Timepoint(s) of evaluation of this end point: at week 0, 4, 8 and 12	—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactClinical Trial Center

Medical University Innsbruck

ctc@i-med.ac.at

Outcome results

None listed

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