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

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ClinicalTrials.gov Identifier: NCT00989807
Recruitment Status : Approved for marketing
First Posted : October 6, 2009
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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


Interventions

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00989807     History of Changes
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:
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