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

NCT00989807 | Unknown

• 1 other identifier: EA-US-205-0122
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Cystic Fibrosis; Pseudomonas Aeruginosa

Keywords

CF; Cystic fibrosis; Pseudomonas aeruginosa; EAP; Expanded access; AZLI; Aztreonam lysine

Interventions

Aztreonam lysine DRUG

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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (4)

University of Calgary, Adult CF Clinic

Calgary, Alberta, T2N4N1, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

St. Michael's Hospital

Toronto, Ontario, T2N4N1, Canada

Location

Centre de Recherche du CHUM

Montreal, Quebec, H2W1T7, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 6, 2009
• Last Updated: December 13, 2012

Record last verified: 2012-10

Locations

CA (4)