Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Conditions
Keywords
Cystic Fibrosis, Pseudomonas aeruginosa, airway infection, Aztreonam Lysine for Inhalation
Brief summary
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.
Interventions
75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
Sponsors
Gilead Sciences
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
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: * Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test * Two well characterized genetic mutations in the CFTR gene * Abnormal nasal potential difference with accompanying symptoms characteristic of CF * At high risk for disease progression as defined by one of the following subject populations: * First Cohort Criteria: * Those who are wait listed or eligible for lung transplant based on FEV1 criteria. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program; or * Completed participation in CP-AI-006 (through Visit 20). Subjects who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol. * Second Cohort Criteria: * Meets first cohort criteria * FEV1 ≤ 40% predicted at the time of consent * Third Cohort Criteria: * Meets first or second cohort criteria * FEV1 ≤ 50% predicted at the time of consent
Exclusion criteria
Subjects who meet any of the following
Countries
Puerto Rico, United States
Outcome results
None listed