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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004829

Sponsors and Collaborators
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 August 21, 2014