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

Sponsor

Gilead Sciences (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT00989807

Collaborator

(none)

Locations

Study Details

Study Description

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 infection who have limited treatment options and are at risk for disease progression.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Pseudomonas Aeruginosa	Drug: Aztreonam lysine

Study Design

Study Type:

Expanded Access

Official 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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary, Adult CF Clinic	Calgary	Alberta	Canada	T2N4N1
2	University of Alberta Hospital	Edmonton	Alberta	Canada
3	St. Michael's Hospital	Toronto	Ontario	Canada	T2N4N1
4	Centre de Recherche du CHUM	Montreal	Quebec	Canada	H2W1T7