Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00989807
• Date of registration: 02/10/2009
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis EAP
• Scientific title: Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
• Date of first enrolment: September 2009
• Recruitment status: Approved for marketing
• URL: http://clinicaltrials.gov/show/NCT00989807
• Study type: Expanded Access
• Study design: N/A
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- = 6 years of age

- Patient has 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

- PA present in expectorated sputum or throat swab culture within 2 months prior to
consent

- Patient must be able to provide written informed consent/assent prior to any study
related procedure; parent/guardian must be able to give written informed consent as
necessary prior to any study related procedure

- At high risk for disease progression as defined by one of the following patient
populations:

- FEV1 = 50 % predicted at the time of consent OR

- Completed participation in CP-AI-006 (through Visit 20). Patients who withdraw from
CP-AI-006 prior to completing all courses of AZLI and all study visits will not be
eligible for this protocol.

Exclusion Criteria:

- Patients with any serious or active medical or psychiatric illness that, in the
opinion of the investigator, 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

- Currently enrolled in another clinical trial

- Pregnant or lactating females



Age minimum: 6 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Pseudomonas Aeruginosa

Intervention(s)

Drug: Aztreonam lysine

Secondary ID(s)

EA-US-205-0122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors