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.
Information provided by (Responsible Party):
First received: October 2, 2009
Last updated: December 12, 2012
Last verified: October 2012
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.
Drug: Aztreonam lysine
What is Expanded Access?
||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
Drug: Aztreonam lysine
Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily
|Ages Eligible for Study:
||6 Years and older
|Genders Eligible for Study:
- ≥ 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989807
|University of Calgary, Adult CF Clinic
|Calgary, Alberta, Canada, T2N4N1 |
|University of Alberta Hospital
|Edmonton, Alberta, Canada |
|St. Michael's Hospital
|Toronto, Ontario, Canada, T2N4N1 |
|Centre de Recherche du CHUM
|Montreal, Quebec, Canada, H2W1T7 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 2, 2009
||December 12, 2012
||Canada: Health Canada
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections