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 Save

Date Added
March 16th, 2018
PRO Number
Pro00072857
Researcher
Daniel e. Brown
Keywords
Cystic Fibrosis
Summary

This is a randomized, double-blind, multi-center study in pediatric
subjects age 3 months to less than 18 years with CF and newly
detected PA respiratory tract colonization/infection. The study
schedule will consist of a minimum of 13 visits: Screening, Day 1
(Baseline and Randomization), Day 29, Weeks 6, 8, 16, and at
12-week intervals thereafter through Week 112. Subjects may be
screened up to 14 days prior to the Baseline visit to determine
eligibility for participation in the study. Screening and Baseline may
occur on the same day for subjects.

Institution
Palmetto
Recruitment Contact
Barbara (Barb) Thompson
803-434-4986
Barbara.Thompson@uscmed.sc.edu

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