Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
1 other identifier
expanded_access
N/A
2 countries
65
Brief Summary
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedAugust 2, 2011
July 1, 2011
July 9, 2007
July 29, 2011
Conditions
Keywords
Interventions
75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
Eligibility Criteria
You may qualify if:
- ≥ 6 years of age
- Subject has CF as diagnosed by one of the following:
- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
- Two well characterized genetic mutations in the CFTR gene
- Abnormal nasal potential difference with accompanying symptoms characteristic of CF
- At high risk for disease progression as defined by one of the following subject populations:
- First Cohort Criteria:
- Those who are wait listed or eligible for lung transplant based on FEV1 criteria. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program; or
- Completed participation in CP-AI-006 (through Visit 20). Subjects who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol.
- Second Cohort Criteria:
- Meets first cohort criteria
- FEV1 ≤ 40% predicted at the time of consent
- Third Cohort Criteria:
- Meets first or second cohort criteria
- FEV1 ≤ 50% predicted at the time of consent
You may not qualify if:
- Subjects with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance with the protocol or dosing requirements
- Subjects with hypersensitivity to any of the components of the drug product
- Currently enrolled in another clinical trial
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (65)
Unknown Facility
Birmingham, Alabama, 35233, United States
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Anchorage, Alaska, 99508, United States
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Phoenix, Arizona, 85016, United States
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Little Rock, Arkansas, 72205, United States
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Los Angeles, California, 90027, United States
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Sacramento, California, 95819, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94143, United States
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Denver, Colorado, 80045, United States
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Denver, Colorado, 80206, United States
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Hartford, Connecticut, 06102, United States
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Hartford, Connecticut, 06106, United States
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Ft, Meyers, Florida, 33908, United States
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Gainesville, Florida, 32610, United States
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Orlando, Florida, 32803, United States
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St. Petersburg, Florida, 33701, United States
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Tampa, Florida, 33606, United States
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Boise, Idaho, 83712, United States
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Chicago, Illinois, 60302, United States
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Chicago, Illinois, 60614, United States
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Maywood, Illinois, 60153, United States
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Des Moines, Iowa, 50309, United States
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Wichita, Kansas, 67214, United States
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New Orleans, Louisiana, 70112, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48201, United States
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Minneapolis, Minnesota, 54404, United States
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Minneapolis, Minnesota, 55455, United States
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Columbia, Missouri, 65212, United States
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Kansas City, Missouri, 64108, United States
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Great Falls, Montana, 59405, United States
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Las Vegas, Nevada, 89107, United States
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Long Branch, New Jersey, 07740, United States
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New Brunswick, New Jersey, 08901, United States
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Albuquerque, New Mexico, 87131, United States
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Albany, New York, 12208-3479, United States
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Buffalo, New York, 14222, United States
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New Hyde Park, New York, 11040, United States
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New York, New York, 10011, United States
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New York, New York, 10032, United States
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Syracuse, New York, 13210, United States
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Valhalla, New York, 10595, United States
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Chapel Hill, North Carolina, 27599-7220, United States
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Akron, Ohio, 44308, United States
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Cincinnati, Ohio, 45229, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43205, United States
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Toledo, Ohio, 43605, United States
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Oklahoma City, Oklahoma, 73104, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19134, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Sioux Falls, South Dakota, 57117, United States
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Memphis, Tennessee, 38103, United States
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Dallas, Texas, 75230, United States
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Fort Worth, Texas, 76104, United States
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San Antonio, Texas, 78212, United States
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Salt Lake City, Utah, 84132-4701, United States
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Norfolk, Virginia, 23507, United States
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Portsmouth, Virginia, 23708, United States
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Richmond, Virginia, 23219, United States
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Seattle, Washington, 98195, United States
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San Juan, 366528, Puerto Rico