Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥ 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
You may not be if
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
Clareo Health | Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
