Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Pseudomonas Aeruginosa
Intervention: Aztreonam lysine (Drug)
Phase: N/A
Status: Approved for marketing
Sponsored by: Gilead Sciences
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.
Clinical Details
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
Study design: N/A
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
University of Calgary, Adult CF Clinic, Calgary, Alberta T2N4N1, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
St. Michael's Hospital, Toronto, Ontario T2N4N1, Canada
Centre de Recherche du CHUM, Montreal, Quebec H2W1T7, Canada
Additional Information
Last updated: December 12, 2012
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