Targeting antibiotics to pseudomonas aeruginosa in small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)
- Conditions
- Cystic FibrosisTaaislijmziekteInhaled antibioticsInhalatie antibioticaPseudomonas aeruginosa
- Registration Number
- NL-OMON27081
- Lead Sponsor
- Erasmus MC, Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Age ≥ 18 years;
FEV1 predicted ≥ 30%;
Exclusion Criteria
Severe acute exacerbation of pulmonary infection (needing intravenous treatment);
Patients receiving intravenous tobramycin treatment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.
- Secondary Outcome Measures
Name Time Method  Maximum tobramycin serum level (Cmax); <br /><br> Time to maximum serum level (Tmax); <br /><br> Trough level of inhaled tobramycin (Ctrough; 24 hours post dose);<br /><br> Adverse events (coughing, bronchospasm).