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

February 24, 2000
June 23, 2005
June 1995
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Complete list of historical versions of study NCT00004829 on ClinicalTrials.gov Archive Site
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Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
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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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Bacterial Infection
Drug: tobramycin
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 1998
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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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004829
199/13390, PATH-PG-TNDS-002/003, PATH-FDR001235
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FDA Office of Orphan Products Development
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Study Chair: Alan Bruce Montgomery Pathogenesis
FDA Office of Orphan Products Development
June 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP