- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00989807
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis (EAP)
December 12, 2012 updated by: Gilead Sciences
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
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.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N4N1
- University of Calgary, Adult CF Clinic
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Edmonton, Alberta, Canada
- University of Alberta Hospital
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Ontario
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Toronto, Ontario, Canada, T2N4N1
- St. Michael's Hospital
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Quebec
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Montreal, Quebec, Canada, H2W1T7
- Centre de Recherche du CHUM
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 2, 2009
First Submitted That Met QC Criteria
October 5, 2009
First Posted (Estimate)
October 6, 2009
Study Record Updates
Last Update Posted (Estimate)
December 13, 2012
Last Update Submitted That Met QC Criteria
December 12, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Pancreatic Diseases
- Fibrosis
- Cystic Fibrosis
- Pseudomonas Infections
- Anti-Infective Agents
- Anti-Bacterial Agents
- Aztreonam
Other Study ID Numbers
- EA-US-205-0122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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