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
Brief Summary

The primary objective of this program is to provide expanded access to aztreonam lysinefor inhalation (AZLI) 75 mg prior to its commercial availability to patients with cysticfibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatmentoptions and are at risk for disease progression.

Approved for marketing
Cystic Fibrosis
Pseudomonas Aeruginosa Airway Infection

Drug: Aztreonam Lysine for Inhalation

75 mg three times a day via inhalation for 28 days followed by 28 days off drug.

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

Eligibility Gender
All
Eligibility Age
Minimum: 6 Years ~ Maximum: N/A
Countries
Puerto Rico
United States
Locations

Birmingham, Alabama, United States

Anchorage, Alaska, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Los Angeles, California, United States

Sacramento, California, United States

San Francisco, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Denver, Colorado, United States

Hartford, Connecticut, United States

Hartford, Connecticut, United States

Ft, Meyers, Florida, United States

Gainesville, Florida, United States

Orlando, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Maywood, Illinois, United States

Des Moines, Iowa, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Columbia, Missouri, United States

Kansas City, Missouri, United States

Great Falls, Montana, United States

Las Vegas, Nevada, United States

Long Branch, New Jersey, United States

New Brunswick, New Jersey, United States

Albuquerque, New Mexico, United States

Albany, New York, United States

Buffalo, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

Syracuse, New York, United States

Valhalla, New York, United States

Chapel Hill, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Ft. Worth, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Portsmouth, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

San Juan, Puerto Rico

Gilead Sciences
NCT Number
Keywords
Cystic fibrosis
Pseudomonas aeruginosa
airway infection
Aztreonam Lysine for Inhalation
MeSH Terms
Infections
Communicable Diseases
Pseudomonas Infections
Cystic Fibrosis
Respiratory Aspiration
Fibrosis
Aztreonam