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

February 24, 2000
February 25, 2000
March 25, 2015
June 1995
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Complete list of historical versions of study NCT00004829 on Archive Site
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Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
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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.

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.

Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Bacterial Infection
Drug: tobramycin
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 1998
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--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
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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FDA Office of Orphan Products Development
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Study Chair: Alan Bruce Montgomery Pathogenesis
FDA Office of Orphan Products Development
June 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP