Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00125346

Purpose

Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Tobramycin Inhalation Powder	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Antibiotics Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.

Secondary Outcome Measures:

Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,

Enrollment:	98
Study Start Date:	September 2005
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
Male and female subjects between 6 and 21 years of age at the time of screening.
FEV1 at screening must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125346

Show 41 Study Locations

Sponsors and Collaborators

Novartis

More Information

Additional Information:

Click here for more information about the study. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	external affairs, novartis
ClinicalTrials.gov Identifier:	NCT00125346 History of Changes
Other Study ID Numbers:	CTBM100C2301
Study First Received:	July 28, 2005
Last Updated:	October 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Tobramycin Inhalation Powder

Additional relevant MeSH terms:

Respiratory Aspiration
Cystic Fibrosis
Fibrosis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases

Lung Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012