Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsored by:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004829

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis Bacterial Infection	Drug: tobramycin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Bacterial Infections Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	200
Study Start Date:	June 1995
Estimated Study Completion Date:	May 1998

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.

Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening

Sweat chloride at least 60 mEq/L

--Prior/Concurrent Therapy--

At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic

At least 4 weeks since prior administration of any investigational drug

No concurrent antibiotics by aerosol

--Patient Characteristics--

Renal:

Creatinine less than 2 mg/dL
BUN less than 40 mg/dL
No proteinuria of 2+ or greater

Pulmonary:

FEV1 at least 75% and at least 25% of predicted
Room air oximetry at least 88% saturation
Able to perform pulmonary function tests
No hemoptysis of 60 mL or greater within 30 days prior to study
No abnormal chest X-ray

Other:

Not pregnant
Fertile females must use effective contraception
No history of positive culture with Burkholderia cepacia
No history of glucose-6-phosphate dehydrogenase deficiency
No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004829

Sponsors and Collaborators

FDA Office of Orphan Products Development

Investigators

Study Chair:

Alan Bruce Montgomery

Pathogenesis

More Information

Publications:

Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30.

Study ID Numbers:	199/13390, PATH-PG-TNDS-002/003, PATH-FDR001235
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004829 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

bacterial infection
cardiovascular and respiratory diseases
cystic fibrosis

genetic diseases and dysmorphic syndromes
immunologic disorders and infectious disorders
rare disease

Study placed in the following topic categories:

Bacterial Infections
Tobramycin
Fibrosis
Respiration Disorders
Rare Diseases
Anti-Bacterial Agents
Digestive System Diseases

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Tobramycin
Fibrosis
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Digestive System Diseases

Pathologic Processes
Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 02, 2009