Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
≥ 6 years of age
Subject has CF as diagnosed by one of the following:
At high risk for disease progression as defined by one of the following subject populations:
First Cohort Criteria:
Second Cohort Criteria:
Third Cohort Criteria:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
Ft, Meyers, Florida 33908, United States