Eligibility Criteria
The Aztreonam Lysine for Inhalation EAP is available through participating treatment centers in the United States to people with cystic fibrosis (CF) with Pseudomonas aeruginosa in their lungs, who have limited or no treatment options and who are at risk for disease progression. You or a loved one must provide informed consent and be screened by a participating doctor to determine eligibility.
Who may be eligible?
ALL of the following eligibility criteria must be met to enroll in this EAP. Specifically, you or your loved one must:
- Be at least 6 years of age
- Have CF as diagnosed by one of the following tests:
- Sweat chloride
- Genetic mutations in the CFTR gene
- Abnormal nasal potential difference with symptoms associated with CF
- Have a confirmed Pseudomonas aeruginosa infection, as determined by expectorated sputum or throat swab culture within 2 months prior to program enrollment
- Be able to provide written informed consent/assent prior to any program-related procedure
- For children under 18, a parent/guardian must be able to give written informed consent as necessary prior to any program-related procedure
- Be at high risk for disease progression as defined by:
- Having an FEV1 ≤ 50% (predicted) at the time of consent; or
- Completion of participation in CP-AI-006/AIR-CF3 (through Visit 20)
Who may NOT be eligible?
You or a loved one may NOT be eligible if you or a loved one:
- Has a serious or active medical or psychiatric (mental) illness that would interfere with treatment, assessment or compliance with the protocol or dosing requirements
- Is allergic to any of the components of the drug product
- Is currently enrolled in another clinical trial
- Is pregnant or breastfeeding
For more information, visit www.clinicaltrials.gov and enter "NCT00499720" in the search tool.
Next: Learn how to enroll