Clinical trial NCT00499720: Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cystic Fibrosis
Pseudomonas Aeruginosa Airway Infection
Keywords: Cystic Fibrosis
Pseudomonas aeruginosa
airway infection
Aztreonam Lysine for Inhalation
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-07-11
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

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.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

* ≥ 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

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
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state: California
city: Sacramento
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state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Ft, Meyers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
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state: Florida
city: Boise
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state: Idaho
city: Chicago
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state: Illinois
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Minneapolis
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state: Minnesota
city: Columbia
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state: Missouri
city: Kansas City
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state: Missouri
city: Great Falls
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state: Montana
city: Las Vegas
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state: Nevada
city: Long Branch
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state: New Jersey
city: New Brunswick
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state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
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state: New York
city: Buffalo
country: United States
state: New York
city: New Hyde Park
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state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
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state: New York
city: Valhalla
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Akron
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state: Ohio
city: Cincinnati
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city: Cleveland
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city: Columbus
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state: Ohio
city: Toledo
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state: Ohio
city: Oklahoma City
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state: Oklahoma
city: Hershey
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state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Portsmouth
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: San Juan
country: Puerto Rico
Study officials:
References: