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

NCT00004829 | Completed Phase 3

• 3 other identifiers: 199/13390PATH-PG-TNDS-002/003PATH-FDR001235
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cystic Fibrosis; Bacterial Infection

Keywords

bacterial infection; cardiovascular and respiratory diseases; cystic fibrosis; genetic diseases and dysmorphic syndromes; immunologic disorders and infectious disorders; rare disease

Interventions

tobramycin DRUG

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead

Related 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. doi: 10.1056/NEJM199901073400104.

  PMID: 9878641 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Bacterial Infections; Respiratory Tract Diseases; Genetic Diseases, Inborn; Immune System Diseases; Communicable Diseases; Rare Diseases

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Alan Bruce Montgomery

  Pathogenesis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: June 1, 1995
• Study Completion: May 1, 1998
• Last Updated: March 25, 2015

Record last verified: 1998-06