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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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00989807
Acronym
EAP
Enrollment
Unknown
Registered
2009-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2012-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Pseudomonas Aeruginosa

Keywords

CF, Cystic fibrosis, Pseudomonas aeruginosa, EAP, Expanded access, AZLI, Aztreonam lysine

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.

Interventions

DRUGAztreonam lysine

Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026