Cystic Fibrosis with Pseudomonas aeruginosa infection
Conditions
Interventions
Product Name: Tobramycin 100 PARI
Product Code: T100 PARI
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Tobramycin
Current Sponsor code: T100 PARI
Concentration unit: mg/ml milligram(s)
Sponsors
PARI GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects with CF >/= 10 years of age • Stable condition with no exacerbation requiring IV antibiotics or hospitalization within a three month period prior to screening visit • Ability to perform reproducible spirometry • Room air oximetry >/= 92% saturation • Stable doses of antibiotics and systemic steroids in the last 3 months • Documented presence of P. aeurginosa infection in the lungs within the past year • Regular use of inhaled tobramycin within the past year Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of investigational medications within 30 days before study entry or during the trial. • FEV1 60 cc at any time within thirty days prior to study drug administration Or resulting in hospital admission • Suspected or proven allergic bronchopulmonary aspergillosis (ABPA) • Known local or systemic hypersensitivity to aminoglycosides. • Serum creatinine > 175 µmol/l or a BUN > 15 mmol/l or ? 2+ proteinuria • Significant liver disease (as evidenced by thrombocytopenia (platelet count < 150,000 per microliter) or hypoalbuminemia (albumin < 35 g/l) or the suspected presence of esophageal varicies • Subjects with history of GI bleeding • New development of CF related diabetes • Presence of B. cepacia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the lung deposition of T100 PARI nebulized by the eFlow® inhaler, and compare that with the lung deposition of registered TOBI® nebulized by the PARI LC PLUS® jet nebulizer. This aim will be accomplished by inhaling doses of radiolabeled tobramycin and measuring lung deposition of the drug using a gamma camera. ;Secondary Objective: Assessment of Pharmacokinetics of Tobramycin ;Primary end point(s): Lung deposition of Tobramycin relative to filled dose | — |
Countries
Germany
Outcome results
None listed