Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
AIR-CF2
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
1 other identifier
interventional
211
1 country
56
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2005
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 1, 2005
CompletedFirst Posted
Study publicly available on registry
March 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedResults Posted
Study results publicly available
March 11, 2011
CompletedMarch 11, 2011
September 1, 2010
1.6 years
March 1, 2005
September 10, 2010
February 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics
The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.
Day 0 to Day 84 (end of study)
Secondary Outcomes (4)
Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score
Day 0 to Day 28
Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)
Day 0 to Day 28
Number of Hospitalization Days
Day 0 to Day 84
Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum
Day 0 to Day 28
Other Outcomes (2)
Number of Participants With Other Pathogens
Day 0 and Day 28
Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)
Day 0 to Day 28
Study Arms (2)
Placebo (pooled two times a day [BID]/three times a day [TID])
PLACEBO COMPARATORAZLI (pooled two times a day [BID]/three times a day [TID])
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- CF as diagnosed by:
- Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or
- Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
- Abnormal nasal potential difference with accompanying symptoms characteristic of CF.
- PA present in expectorated sputum or throat swab culture at Screening.
- Participants must have received three or more courses of TIS within the previous 12 months.
- Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.
- Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening.
- Ability to perform reproducible pulmonary function tests.
- Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.
You may not qualify if:
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day.
- History of sputum or throat culture swab yielding Burkholderia cepacia in the past 2 years.
- History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
- Administration of any investigational drug or device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer).
- Known local or systemic hypersensitivity to monobactam antibiotics.
- Inability to tolerate inhalation of a short acting Beta-2 agonist.
- Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit.
- Changes in physiotherapy technique or schedule within 7 days before Screening or between Screening and the next visit.
- History of lung transplantation.
- A chest X-ray indicating abnormal findings at Screening or within the previous 90 days.
- Abnormal renal or hepatic function or serum chemistry at Screening (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] greater than 5 times the upper limit of normal range; Creatinine greater than 2 times the upper limit of normal range).
- Positive pregnancy test at Screening.
- Female of childbearing potential who was lactating or in the opinion of the investigator was not practicing acceptable 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (56)
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente Medical Care Program
Oakland, California, United States
Children's Hospital, Orange Co.
Orange, California, United States
Stanford University Hospital and Medical Center
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Children's Hospital
Denver, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
University of Florida Health Sciences Center
Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville
Jacksonville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
Pediatric Pulmonary Associates, Florida
St. Petersburg, Florida, United States
Emory Healthcare
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Children's Memorial Hospital/Northwestern University
Chicago, Illinois, United States
Chicago Children's Asthma Respiratory and Exercise Specialists
Glenview, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
North Suburban Pulmonary / Critical Care Consultants
Niles, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Maine Medical Center
Portland, Maine, United States
Children's Hospital, Boston
Boston, Massachusetts, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Lung Specialists, Ltd.
Las Vegas, Nevada, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Albany Medical College
Albany, New York, United States
Long Island College Hospital
Brooklyn, New York, United States
Children's Hospital of Buffalo
Buffalo, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Columbia University Medical Center
New York, New York, United States
State University of New York Stony Brook
Stony Brook, New York, United States
Children's Hospital of Westchester Medical Center/New York Medical College
Valhalla, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Columbus Children's Hospital, Ohio State University
Columbus, Ohio, United States
Children's Medical Center
Dayton, Ohio, United States
Dr. Santiago Reyes
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State University Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburg
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Pediatric Pulmonary Associates, South Carolina
Columbia, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
Pediatric Pulmonary Center
Richmond, Virginia, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Related Publications (2)
Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest. 2009 Jun;135(6):1610-1618. doi: 10.1378/chest.08-1190. Epub 2009 May 15.
PMID: 19447923DERIVEDMcCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24.
PMID: 18658109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was designed such that participants were discontinued from study participation upon meeting the primary endpoint (time to need for inhaled or IV antipseudomonal antibiotics).
Results Point of Contact
- Title
- Mark Bresnik, MD, Director, Clinical Research
- Organization
- Gilead Sciences, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Karen McCoy, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 1, 2005
First Posted
March 2, 2005
Study Start
February 1, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
March 11, 2011
Results First Posted
March 11, 2011
Record last verified: 2010-09