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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00989807
First received: October 2, 2009
Last updated: December 12, 2012
Last verified: October 2012
  Purpose

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 Intervention
Cystic Fibrosis
Pseudomonas Aeruginosa
Drug: Aztreonam lysine

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989807

Locations
Canada, Alberta
University of Calgary, Adult CF Clinic
Calgary, Alberta, Canada, T2N4N1
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, T2N4N1
Canada, Quebec
Centre de Recherche du CHUM
Montreal, Quebec, Canada, H2W1T7
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00989807     History of Changes
Other Study ID Numbers: EA-US-205-0122
Study First Received: October 2, 2009
Last Updated: December 12, 2012
Health Authority: Canada: Health Canada

Keywords provided by Gilead Sciences:
CF
Cystic fibrosis
Pseudomonas aeruginosa
EAP
Expanded access
AZLI
Aztreonam lysine

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014