Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progressio

• Conditions: Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.; MedDRA version: 17.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000397-36-Outside-EU/EEA
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 45

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 00 predicted at the time of consent
Or
Completed participation in CP-Al-006 (through Visit 20). Patients who withdraw
from CP-Al-006 prior to completing all courses of AZLI and all study visits will
not be eligible for this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to provide expanded access to AZLI 75 mg prior to its commercial availability and establishment of reimbursement programs through Provincial Ministries of Health to patients in Canada with CF and PA airway infection who have limited treatment options and are at risk for disease progression.;Secondary Objective: Not applicable.;Primary end point(s): Not applicable: Expanded Access Program;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable