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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00499720
First received: July 9, 2007
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Pseudomonas Aeruginosa Airway Infection
Drug: Aztreonam Lysine for Inhalation

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Intervention Details:
    Drug: Aztreonam Lysine for Inhalation
    75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499720

  Show 65 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Debra Cibene/Senior Clinical Research Associate, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00499720     History of Changes
Other Study ID Numbers: EA-US-205-0111
Study First Received: July 9, 2007
Last Updated: July 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Cystic Fibrosis
Pseudomonas aeruginosa
airway infection
Aztreonam Lysine for Inhalation

Additional relevant MeSH terms:
Respiratory Aspiration
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Disease Progression
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Disease Attributes
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014