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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Aztreonam Lysine for Inhalation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings