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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004829
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Bacterial Infection Drug: tobramycin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 1995
Study Completion Date : May 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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--


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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004829

Sponsors and Collaborators
FDA Office of Orphan Products Development
Study Chair: Alan Bruce Montgomery Pathogenesis

Publications: Identifier: NCT00004829     History of Changes
Other Study ID Numbers: 199/13390
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: June 1998

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

Additional relevant MeSH terms:
Cystic Fibrosis
Bacterial Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents