ung 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
Phase 1
- Conditions
- Chronic lung P. Aeruginosa InfectionMedDRA version: 16.1Level: PTClassification code 10061229Term: Lung infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-004295-35-AT
- Lead Sponsor
- Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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
- patients with CF related liver disease or renal disease
- pregnant and nursing women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable