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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

Page last updated: August 20, 2015

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