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

Cystic Fibrosis Clinical Trial

— EAP  

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00989807
• Other study ID #: EA-US-205-0122
• Status: Approved for marketing
• Phase: N/A
• First received: October 2, 2009
• Last updated: December 12, 2012

Study information

• Verified date: October 2012
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Drug:
• Aztreonam lysine
Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily

Locations

Country	Name	City	State
Canada	University of Calgary, Adult CF Clinic	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Centre de Recherche du CHUM	Montreal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Canada,