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

• Status: Completed
• Trial end date: 1998-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Treatments: Tobramycin

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