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

Status:

APPROVED_FOR_MARKETING

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

Lead Sponsor:

Gilead Sciences

Conditions:

Cystic Fibrosis

Pseudomonas Aeruginosa

Eligibility:

All Genders

6+ years

Brief Summary

This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infecti...

Eligibility Criteria

Inclusion

≥ 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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00989807

Last Update

December 13 2012

Active Locations (4)

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Page 1 of 1 (4 locations)

University of Calgary, Adult CF Clinic

Calgary, Alberta, Canada, T2N4N1

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Michael's Hospital

Toronto, Ontario, Canada, T2N4N1