Back to resultsExpanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis (EAP)
Primary Purpose
Cystic Fibrosis, Pseudomonas Aeruginosa
Status
Approved for marketing
Phase
Locations
Canada
Study Type
Expanded Access
Intervention
Aztreonam lysine
Sponsored by
About this trial
This is an expanded access trial for Cystic Fibrosis focused on measuring CF, Cystic fibrosis, Pseudomonas aeruginosa, EAP, Expanded access, AZLI, Aztreonam lysine
Eligibility 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
Sites / Locations
- University of Calgary, Adult CF Clinic
- University of Alberta Hospital
- St. Michael's Hospital
- Centre de Recherche du CHUM
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00989807
Brief Title
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis
Acronym
EAP
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 Type
Expanded Access
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Pseudomonas Aeruginosa
Keywords
CF, Cystic fibrosis, Pseudomonas aeruginosa, EAP, Expanded access, AZLI, Aztreonam lysine
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aztreonam lysine
Intervention Description
Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Eligibility 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
Facility Information:
Facility Name
University of Calgary, Adult CF Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
Centre de Recherche du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W1T7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis
We'll reach out to this number within 24 hrs