The primary objective of this program is to provide expanded access to aztreonam lysinefor inhalation (AZLI) 75 mg prior to its commercial availability to patients with cysticfibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatmentoptions and are at risk for disease progression.
Drug: Aztreonam Lysine for Inhalation
75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
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 exclusion criteria are not to be enrolled in this
study:
- Subjects with any serious or active medical or psychiatric illness that, in the
opinion of the investigator, would interfere with subject treatment, assessment or
compliance with the protocol or dosing requirements
- Subjects with hypersensitivity to any of the components of the drug product
- Currently enrolled in another clinical trial
- Pregnant or lactating females
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