Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00634192

Purpose

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' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last 8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1<80% predicted).

Condition	Intervention	Phase
Pseudomonas Infections	Drug: tobramycin	Phase III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Multicenter, Open Label, 2 Period Cross-Over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the serum pharmacokinetics (PK) of inhaled tobramycin (AUC0-90') of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebuliser Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects [ Time Frame: 8 wks ]

Secondary Outcome Measures:

Serum PK of tobramycin of continuous daily dosing regimens. Serum PK of tobramycin in CF-Subjects with a FEV1≥80% vs. CF-Subjects with a FEV1<80%. Change of MIC of P aeruginosa in both treatments. Safety of a continuous daily dosing regimen [ Time Frame: 8 wks ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tobramycin 1x300mg/d inhaled
2: Experimental	Drug: tobramycin 2x300mg/d inhaled

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634192

Contacts

Contact: Novartis Pharma AG

+41 61 324 1111

Locations

Germany
Novartis Investigator site	Recruiting
Nurnburg, Germany
Contact +41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharma AG

Novartis

More Information

Study ID Numbers:	CTBM100DDE01
Study First Received:	March 4, 2008
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00634192
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Chronic infection with P. aeruginosa in Cystic Fibrosis subjects

Study placed in the following topic categories:

Bacterial Infections
Tobramycin
Cystic Fibrosis
Pseudomonas Infections

Fibrosis
Cystic fibrosis
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009