CLINICAL TRIALS PROFILE FOR TOBRAMYCIN

All Clinical Trials for Tobramycin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004829 ↗	Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis	Completed	FDA Office of Orphan Products Development	Phase 3	1995-06-01	OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
NCT00006280 ↗	A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis	Completed	National Center for Research Resources (NCRR)	Phase 2	2000-02-01	This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
NCT00006280 ↗	A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2000-02-01	This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
NCT00097773 ↗	Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis	Completed	CF Therapeutics Development Network Coordinating Center	Phase 2	2004-09-01	Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.
NCT00097773 ↗	Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis	Completed	Cystic Fibrosis Foundation	Phase 2	2004-09-01	Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.

Clinical Trial Conditions for Tobramycin

Condition Name

Condition Name for Tobramycin
Intervention	Trials
Cystic Fibrosis	48
Cataract	5
Pseudomonas Aeruginosa	4
Fractures, Open	3

Condition MeSH

Condition MeSH for Tobramycin
Intervention	Trials
Cystic Fibrosis	55
Fibrosis	50
Pseudomonas Infections	17
Infections	11

Clinical Trial Locations for Tobramycin

Trials by Country

Trials by Country for Tobramycin
Location	Trials
United States	490
Italy	55
Spain	20
Canada	19
France	19

Trials by US State

Trials by US State for Tobramycin
Location	Trials
Ohio	22
Pennsylvania	22
New York	22
Texas	22
Florida	21

Clinical Trial Progress for Tobramycin

Clinical Trial Phase

Clinical Trial Phase for Tobramycin
Clinical Trial Phase	Trials
Phase 4	33
Phase 3	37
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tobramycin
Clinical Trial Phase	Trials
Completed	76
Unknown status	15
Terminated	10

Clinical Trial Sponsors for Tobramycin

Sponsor Name

Sponsor Name for Tobramycin
Sponsor	Trials
Novartis Pharmaceuticals	15
Cystic Fibrosis Foundation	8
Bausch & Lomb Incorporated	7

Sponsor Type

Sponsor Type for Tobramycin
Sponsor	Trials
Other	148
Industry	77
NIH	5