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Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis; Pseudomonas Aeruginosa Airway Infection

Intervention: Aztreonam Lysine for Inhalation (Drug)

Phase: N/A

Status: Approved for marketing

Sponsored by: Gilead Sciences


The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.

Clinical Details

Official title: Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression

Study design: N/A


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


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


- Two well characterized genetic mutations in the CFTR gene

- Abnormal nasal potential difference with accompanying symptoms characteristic of


- At high risk for disease progression as defined by one of the following subject


- 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

Locations and Contacts

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Additional Information

Last updated: July 29, 2011

Page last updated: August 20, 2015

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