Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)

NCT ID: NCT00128492

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-01-31

Brief Summary

The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Detailed Description

People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.

A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AZLI 75 mg two times a day (BID)/ three times a day (TID)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.
• Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.
• Ability to provide written informed consent/assent prior to initiation of study-related procedures.
• Ability to perform reproducible pulmonary function tests.

Exclusion Criteria

• Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.
• Concurrent participation in a study of another investigational drug or device.
• Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
• History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.
• History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
• Inability to tolerate study medication in CP-AI-005 or CP-AI-007.
• Known local or systemic hypersensitivity to aztreonam.
• Inability to tolerate inhalation of a short acting beta-2 agonist.
• Abnormal renal or hepatic function based on results of most recent test.
• Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.
• Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Clinical Research, Gilead Sciences, Inc.

Principal Investigators

Bruce Montgomery, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Birmingham, Alabama, United States

Anchorage, Alaska, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

La Jolla, California, United States

Los Angeles, California, United States

Oakland, California, United States

Orange, California, United States

Denver, Colorado, United States

Hartford, Connecticut, United States

New Haven, Connecticut, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Chicago, Illinois, United States

Glenview, Illinois, United States

Maywood, Illinois, United States

Park Ridge, Illinois, United States

Indianapolis, Indiana, United States

Wichita, Kansas, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Columbia, Missouri, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Livingston, New Jersey, United States

Morristown, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

New Hyde Park, 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

Columbus, Ohio, United States

Dayton, Ohio, United States

Oklahoma City, Oklahoma, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Charleston, South Carolina, United States

Columbia, South Carolina, United States

Houston, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Portsmouth, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Morgantown, West Virginia, United States

Westmead, New South Wales, Australia

Herston, Queensland, Australia

Adelaide, South Australia, Australia

Prahan, Victoria, Australia

Nedlands, Western Australia, Australia

Perth, Western Australia, Australia

Edmonton, Alberta, Canada

London, Ontario, Canada

Auckland, , New Zealand

Countries

United States; Australia; Canada; New Zealand

Other Identifiers

CP-AI-006

Identifier Type: -

Identifier Source: org_study_id