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Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis; Pseudomonas Aeruginosa Airway Infection

Intervention: Aztreonam Lysine for Inhalation (Drug)

Phase: N/A

Status: Approved for marketing

Sponsored by: Gilead Sciences

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.

Clinical Details

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 design: N/A

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

San Juan 366528, Puerto Rico

Birmingham, Alabama 35233, United States

Anchorage, Alaska 99508, United States

Phoenix, Arizona 85016, United States

Little Rock, Arkansas 72205, United States

Los Angeles, California 90027, United States

Sacramento, California 95819, United States

San Francisco, California 94115, United States

San Francisco, California 94143, United States

Denver, Colorado 80045, United States

Denver, Colorado 80206, United States

Hartford, Connecticut 06102, United States

Hartford, Connecticut 06106, United States

Ft, Meyers, Florida 33908, United States

Gainesville, Florida 32610, United States

Orlando, Florida 32803, United States

St. Petersburg, Florida 33701, United States

Tampa, Florida 33606, United States

Boise, Idaho 83712, United States

Chicago, Illinois 60614, United States

Chicago, Illinois 60302, United States

Maywood, Illinois 60153, United States

Des Moines, Iowa 50309, United States

Wichita, Kansas 67214, United States

New Orleans, Louisiana 70112, United States

Boston, Massachusetts 02114, United States

Boston, Massachusetts 02111, United States

Detroit, Michigan 48201, United States

Minneapolis, Minnesota 54404, United States

Minneapolis, Minnesota 55455, United States

Columbia, Missouri 65212, United States

Kansas City, Missouri 64108, United States

Great Falls, Montana 59405, United States

Las Vegas, Nevada 89107, United States

Long Branch, New Jersey 07740, United States

New Brunswick, New Jersey 08901, United States

Albuquerque, New Mexico 87131, United States

Albany, New York 12208-3479, United States

Buffalo, New York 14222, United States

New Hyde Park, New York 11040, United States

New York, New York 10032, United States

New York, New York 10011, United States

Syracuse, New York 13210, United States

Valhalla, New York 10595, United States

Chapel Hill, North Carolina 27599-7220, United States

Akron, Ohio 44308, United States

Cincinnati, Ohio 45229, United States

Cleveland, Ohio 44106, United States

Columbus, Ohio 43205, United States

Toledo, Ohio 43605, United States

Oklahoma City, Oklahoma 73104, United States

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania 19104, United States

Philadelphia, Pennsylvania 19134, United States

Pittsburgh, Pennsylvania 15213, United States

Sioux Falls, South Dakota 57117, United States

Memphis, Tennessee 38103, United States

Dallas, Texas 75230, United States

Ft. Worth, Texas 76104, United States

San Antonio, Texas 78212, United States

Salt Lake City, Utah 84132-4701, United States

Norfolk, Virginia 23507, United States

Portsmouth, Virginia 23708, United States

Richmond, Virginia 23219, United States

Seattle, Washington 98195, United States

Additional Information


Last updated: July 29, 2011

Page last updated: August 20, 2015

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