Patient Entry Criteria

Cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa who have limited or no treatment options and are at risk for disease progression may be eligible if they meet all entry criteria. Below are the inclusion and exclusion criteria for the program.

Inclusion criteria

Patients must meet ALL of the following to be eligible for enrollment:

• Patients must be at least 6 years of age
• Patients must have CF as diagnosed by one of the following:
  • Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test; or
  • Two well-characterized genetic mutations in the CFTR gene; or
  • Abnormal nasal potential difference with accompanying symptoms characteristic of CF
• Pseudomonas aeruginosa must be present in expectorated sputum or throat swab culture within two months prior to consent
• Patients must be able to provide written informed consent/assent prior to any program-related procedure
  • For patients under 18, a parent/guardian must be able to give written informed consent as necessary prior to any program-related procedure
• Patients must be at 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)

Exclusion criteria

Patients who meet any of the following exclusion criteria may NOT be enrolled:

• Patients with any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements
• Patients with hypersensitivity to any of the components of the drug product
• Patients currently enrolled in any clinical trial
• Pregnant or breastfeeding females

For more information, visit clinicaltrials.gov and enter "NCT00499720" in the search tool.

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