Aztreonam for Inhalation Solution (AZLI) vs Tobramycin Inhalation Solution (TOBI®) in Patients With CF & P. Aeruginosa
Summary
The purpose of this study is to assess the comparative safety and effectiveness of Aztreonam for Inhalation Solution versus Tobramycin Nebuliser Solution in adult and pediatric patients with CF and pulmonary Pseudomonas aeruginosa (PA) infection.
Description
Number of Subjects Planned: Approximately 200 randomized patients
Target Population: CF patients >/= 6 years of age with stable pulmonary disease, who at study entry have a recent positive sputum culture for PA and have been previously treated with aerosolized antibiotics without demonstration of drug intolerance.
U.S Only
Study Design: This is an open-label, multicenter, randomized, parallel group study. The study design consists of two treatment arms of 28-day, intermittent, repeating treatment regimens: Aztreonam for Inhalation Solution (AZLI) or Tobramycin Inhalation Solution (TIS). The total study period will be 26 weeks. The study schedule will include nine visits - Screening, Baseline, Day 14, Day 28, then visits every 28 days through the end of the study.
EU Only
Study Design: This is an open-label, multicenter, randomized, parallel group study. The study design consists of two treatment arms of 28-day, intermittent, repeating treatment regimens: Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) or Tobramycin Nebuliser Solution (TNS). The total study period will be 26 weeks. The study schedule will include nine visits - Screening, Baseline, Day 14, Day 28, then visits every 28 days through the end of the study.
An open-label, single-arm extension is available for subjects who have completed at least one course of AZLI or TNS during the randomized portion of the study. Subjects may be eligible to receive three additional cycles of AZLI in a 28-day, intermittent, repeating treatment regimen.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Cystic Fibrosis
Intervention
Aztreonam for Inhalation Solution, Tobramycin Nebuliser Solution
Location
Anchorage
Alaska
United States
99508
Status
Recruiting
Source
Gilead Sciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00757237
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Saline Solution, Hypertonic
Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
Osmotic Pressure
The pressure required to prevent the passage of solvent through a semipermeable membrane that separates a pure solvent from a solution of the solvent and solute or that separates different concentrations of a solution. It is proportional to the osmolality of the solution.
Glucose Solution, Hypertonic
Solution that is usually 10 percent glucose but may be higher. An isotonic solution of glucose is 5 percent.
Cystic Fibrosis
An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.
Cystic Fibrosis Transmembrane Conductance Regulator
A chloride channel that regulates secretion in many exocrine tissues. Abnormalities in the CFTR gene have been shown to cause cystic fibrosis. (Hum Genet 1994;93(4):364-8)
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