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

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    tobramycin ...
  • Study Participants

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.
Study Started
Jun 30
Study Completion
May 31
Last Update
Mar 25

Drug tobramycin



--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
No Results Posted