Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

Exclusion Criteria

• •Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening
• •Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (screening visit)
• •History of intolerance to inhaled short acting β2 agonists
• •History of lung transplantation
• •Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night
• •Hospitalization for a respiratory event within 30 days prior to screening
• •Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening.
• •Significant changes (per investigators discretion) in physiotherapy technique or schedule within 7 days prior to screening
• •Abnormal renal or hepatic function results at most recent test within the previous 12 months, defined as Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (ULN), or Serum creatinine \> 2 times ULN for age
• •Presence of a condition or abnormality that would compromise the subject's safety or the quality of the study data, in the opinion of the Investigator
• •Known hypersensitivity to aztreonam, its metabolites, or formulation excipients in AZLI
• •Respiratory cultures performed within 24 months prior to screening that are positive for ANY Burkholderia spp. or Non-tuberculous mycobacteria (NTM)