INHALED AZTREONAM FOR CYSTIC FIBROSIS

Information

  • Research Project
  • 7061986
  • ApplicationId
    7061986
  • Core Project Number
    R01FD003016
  • Full Project Number
    1R01FD003016-01A1
  • Serial Number
    3016
  • FOA Number
    RFA-FD-05-04
  • Sub Project Id
  • Project Start Date
    3/15/2006 - 18 years ago
  • Project End Date
    3/14/2007 - 17 years ago
  • Program Officer Name
    GANTI, USHA
  • Budget Start Date
    3/15/2006 - 18 years ago
  • Budget End Date
    3/14/2007 - 17 years ago
  • Fiscal Year
    2006
  • Support Year
    1
  • Suffix
    A1
  • Award Notice Date
    2/16/2007 - 17 years ago
Organizations

INHALED AZTREONAM FOR CYSTIC FIBROSIS

[unreadable] DESCRIPTION: [unreadable] Pulmonary infection with gram-negative bacteria, particularly Pseudomonas aeruginosa (PA), is the primary cause of death in cystic fibrosis (CF) patients. Control of PA involves intensive antibiotic therapy with intravenous and/or inhaled antibiotics. Inhaled administration achieves high drug concentrations in the lung with reduced systemic exposure. Aztreonam is very effective against PA, and its use should not contribute to the emergence of aminoglycoside-resistant strains of PA due to its mechanism of action. This Phase 3 trial seeks to determine the ability of inhaled aztreonam (AI) to maintain or improve the clinical status following a 28-day course of tobramycin solution for inhalation. Patients will receive a 28-day course of 75 mg AI or volume matched placebo twice or three times daily via eFlow electronic nebulizer. The primary endpoint is the time to need intravenous or inhaled antibiotic treatment from the start of AI/placebo based on the presence of at least one of four symptoms predictive of pulmonary exacerbation. [unreadable] [unreadable]

IC Name
FOOD AND DRUG ADMINISTRATION
  • Activity
    R01
  • Administering IC
    FD
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
  • Ed Inst. Type
  • Funding ICs
  • Funding Mechanism
  • Study Section
    ZFD1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    CORUS PHARMA, INC.
  • Organization Department
  • Organization DUNS
  • Organization City
    SEATTLE
  • Organization State
    WA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    981212158
  • Organization District
    UNITED STATES