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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004829
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: June 1998
History of Changes
  Purpose

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 Intervention Phase
Cystic Fibrosis
Bacterial Infection
 Drug: tobramycin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 200
Study Start Date: June 1995
Estimated Study Completion Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004829

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

Publications:

ClinicalTrials.gov Identifier: NCT00004829     History of Changes
Other Study ID Numbers: 199/13390, PATH-PG-TNDS-002/003, PATH-FDR001235
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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:
Bacterial Infections
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013