Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF
- Conditions
- Cystic Fibrosis with Pseudomonas aeruginosa infection
- Registration Number
- EUCTR2007-000959-33-DE
- Lead Sponsor
- PARI GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
• 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
• Use of investigational medications within 30 days before study entry or during the trial.
• FEV1 • Significant Hemoptysis (eg >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Secondary Objective: Assessment of Pharmacokinetics of Tobramycin<br>;Primary end point(s): Lung deposition of Tobramycin relative to filled dose
- Secondary Outcome Measures
Name Time Method