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

July 29, 2011 updated by: Gilead Sciences

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

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 366528
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Los Angeles, California, United States, 90027
      • Sacramento, California, United States, 95819
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94143
    • Colorado
      • Denver, Colorado, United States, 80206
      • Denver, Colorado, United States, 80045
    • Connecticut
      • Hartford, Connecticut, United States, 06106
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Ft, Meyers, Florida, United States, 33908
      • Gainesville, Florida, United States, 32610
      • Orlando, Florida, United States, 32803
      • St. Petersburg, Florida, United States, 33701
      • Tampa, Florida, United States, 33606
    • Idaho
      • Boise, Idaho, United States, 83712
    • Illinois
      • Chicago, Illinois, United States, 60614
      • Chicago, Illinois, United States, 60302
      • Maywood, Illinois, United States, 60153
    • Iowa
      • Des Moines, Iowa, United States, 50309
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Minneapolis, Minnesota, United States, 54404
    • Missouri
      • Columbia, Missouri, United States, 65212
      • Kansas City, Missouri, United States, 64108
    • Montana
      • Great Falls, Montana, United States, 59405
    • Nevada
      • Las Vegas, Nevada, United States, 89107
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
      • New Brunswick, New Jersey, United States, 08901
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Albany, New York, United States, 12208-3479
      • Buffalo, New York, United States, 14222
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10032
      • New York, New York, United States, 10011
      • Syracuse, New York, United States, 13210
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7220
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43205
      • Toledo, Ohio, United States, 43605
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19134
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
    • Tennessee
      • Memphis, Tennessee, United States, 38103
    • Texas
      • Dallas, Texas, United States, 75230
      • Ft. Worth, Texas, United States, 76104
      • San Antonio, Texas, United States, 78212
    • Utah
      • Salt Lake City, Utah, United States, 84132-4701
    • Virginia
      • Norfolk, Virginia, United States, 23507
      • Portsmouth, Virginia, United States, 23708
      • Richmond, Virginia, United States, 23219
    • Washington
      • Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria

July 9, 2007

First Posted (Estimate)

July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA-US-205-0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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