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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00989807
Expanded Access Status : Approved for marketing
First Posted : October 6, 2009
Last Update Posted : December 13, 2012
Information provided by (Responsible Party):
Gilead Sciences

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
Cystic Fibrosis Pseudomonas Aeruginosa Drug: Aztreonam lysine

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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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00989807

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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
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Responsible Party: Gilead Sciences Identifier: NCT00989807    
Other Study ID Numbers: EA-US-205-0122
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: October 2012
Keywords provided by Gilead Sciences:
Cystic fibrosis
Pseudomonas aeruginosa
Expanded access
Aztreonam lysine
Additional relevant MeSH terms:
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Pseudomonas Infections
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents