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

NCT ID: NCT00989807

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis Pseudomonas Aeruginosa

Keywords

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CF Cystic fibrosis Pseudomonas aeruginosa EAP Expanded access AZLI Aztreonam lysine

Interventions

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Aztreonam lysine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Calgary, Adult CF Clinic

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Centre de Recherche du CHUM

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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EA-US-205-0122

Identifier Type: -

Identifier Source: org_study_id