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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000959-33-DE
• Date of registration: 04/04/2007
• Prospective Registration: Yes
• Primary sponsor: PARI GmbH
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 16/08/2007
• Target sample size: 25
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000959-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: Double blind: Parallel group: Cross over: yes Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic Fibrosis with Pseudomonas aeruginosa infection

Intervention(s)

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)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: TOBI®
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Tobramycin
Current Sponsor code: TOBI®
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

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.

Primary end point(s): Lung deposition of Tobramycin relative to filled dose

Secondary Objective: Assessment of Pharmacokinetics of Tobramycin

Secondary ID(s)

CTP G007.04