for people ages 3 months to 18 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Ngoc Ly
Photo of Ngoc Ly
Ngoc Ly



The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new onset Pseudomonas aeruginosa respiratory tract infection.

Official Title

Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization


Pseudomonas Aeruginosa Respiratory Tract Infection Cystic Fibrosis Infection Communicable Diseases Respiratory Tract Infections Pseudomonas Infections Fibrosis AZLI


You can join if…

Open to people ages 3 months to 18 years

  • Diagnosis of Cystic Fibrosis (CF) as determined by the 2008 CF Consensus Conference criteria: Sweat chloride level ≥ 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF
  • Documented new onset of positive respiratory tract culture for PA within 30 days of screening defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
  • Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years of age who can reliably perform spirometry assessments)
  • Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization

You CAN'T join if...

  • 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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply


  • University of California San Francisco (UCSF) - Benioff Children's Hospital
    San Francisco California 94158 United States
  • University of Utah
    Salt Lake City Utah 84132 United States

Lead Scientist at UCSF

  • Ngoc Ly
    My research has focused on the influences of heredity, as well as prenatal and infant environmental exposures ( including environmental, microbial, and nutritional influences) on immune responses and clinical symptoms of allergy and asthma.


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 3
Study Type
Last Updated