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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

October 2, 2009
December 12, 2012
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Complete list of historical versions of study NCT00989807 on ClinicalTrials.gov Archive Site
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Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis
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

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.

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Expanded Access
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  • Cystic Fibrosis
  • Pseudomonas Aeruginosa
Drug: Aztreonam lysine
Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
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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
Both
6 Years and older
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Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00989807
EA-US-205-0122
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Gilead Sciences
Gilead Sciences
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Gilead Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP