Status:
COMPLETED
Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin
Lead Sponsor:
Novartis
Conditions:
Pseudomonas Infections
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebuliz...
Eligibility Criteria
Inclusion
- Male and female subjects aged ≥6 years at the time of screening, with an Informed Consent Form signed by patient and if appropriate by parent/legal guardians, prior to any study-related procedure.
- Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to a quantitative pilocarpine iontophoresis sweat chloride test of \>60 mEq/L; or identification of well-characterized disease-causing mutations in each CFTR gene; or an abnormal nasal transepithelial potential difference characteristic of CF.
- P aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage \[BAL\]) at the screening visit and within 6 months prior to screening.
Exclusion
- History of sputum (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
- FEV1 \<25% of normal predicted values for age, sex, and height based on Knudson criteria at screening.
- Hemoptysis of more than 60 cc at any time within 30 days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- GFR\<60ml/min/1.73m2 calculated with the Formula by Schwartz, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria.
- History of tinnitus or pathologic audiometry
- diagnosis of Allergic bronchopulmonary aspergillosis (ABPA) at screening
- Initiation of treatment with macrolide antibiotics within 28 days prior to study drug administration (subjects may be taking macrolide antibiotics at the time of enrollment, but they must have initiated treatment at least 28 days prior to study drug administration).
- Use of loop diuretics within 7 days prior to study drug administration.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00634192
Start Date
February 1 2008
End Date
August 1 2009
Last Update
February 24 2017
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigator Site
Berlin, Germany
2
Novartis Investigator Site
Cologne, Germany
3
Novartis Investigator Site
Frankfurt, Germany
4
Novartis Investigator site
Halle, Germany