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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004829
• Other study ID #: 199/13390
• Secondary ID: PATH-PG-TNDS-002
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: March 24, 2015
• Start date: June 1995
• Est. completion date: May 1998

Study information

• Verified date: June 1998
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• tobramycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

References & Publications (1)

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. — View Citation