International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
AIR-CF1
A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
1 other identifier
interventional
166
4 countries
53
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of a 28-day course 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 May 2005
53 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
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 1, 2005
CompletedFirst Posted
Study publicly available on registry
June 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedResults Posted
Study results publicly available
April 21, 2011
CompletedApril 21, 2011
March 1, 2011
1.9 years
June 1, 2005
September 10, 2010
March 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in CFQ-R Respiratory Symptoms Scale (RSS) Score
The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).
Day 0 to Day 28
Secondary Outcomes (6)
Change in CFQ-R RSS Score
Day 0 to Day 14
Change in CFQ-R RSS Score
Day 0 to Day 42
Percent Change in FEV1 (L)
Day 0 to Day 28
Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum
Day 0 to Day 28
Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug
Day 0 to Day 42
- +1 more secondary outcomes
Other Outcomes (3)
Number of Participants With Other Pathogens Present
Day 0 to Day 28
Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)
Day 0
Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)
Day 28
Study Arms (2)
Placebo three times a day (TID)
PLACEBO COMPARATORAZLI 75 mg three times a day (TID)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT);
- Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
- Abnormal nasal potential difference.
- PA present in expectorated sputum or throat swab culture at Screening.
- FEV1 between (and including) 25% and 75% predicted at Screening.
- Negative pregnancy test at Screening.
- Ability to perform reproducible pulmonary function tests.
- Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.
- Ability to provide written informed consent.
You may not qualify if:
- Administration of antipseudomonal antibiotics by inhalation, IV, or oral routes (including azithromycin) within 14 days of Screening.
- 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.
- Administration of any investigational drug or use of any investigational device within 28 days of Screening and within 6 half-lives of the investigational drug (whichever was longer).
- Known local or systemic hypersensitivity to monobactam antibiotics.
- Inability to tolerate short-acting bronchodilator use at least three times daily.
- Changes in protocol-permitted antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days prior to Screening or between Screening and the next visit.
- Changes in physiotherapy technique or schedule within 7 days prior to 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 at Screening.
- 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.
- Use of aerosolized hypertonic saline (except for sputum induction) during the 14 days preceding Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (53)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Pediatric Breathing Disorders Clinic
Anchorage, Alaska, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital, Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Capital Allergy and Respiratory Disease Center
Sacramento, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida Health Sciences Center
Gainesville, Florida, United States
Nemours Children's Clinic, Orlando
Orlando, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Children's Memorial Hospital / Northwestern University
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Via Christi - St. Francis Regional Medical Center
Wichita, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Central Maine Pulmonary Associates
Auburn, Maine, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri
Columbia, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Children's Lung Specialists
Las Vegas, Nevada, United States
St. Barnabas Healthcare System
Livingston, New Jersey, United States
Albany Medical College
Albany, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Pediatric Pulmonary Associates, South Carolina
Columbia, South Carolina, United States
Baylor Martha Foster Lung Care Center
Dallas, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Naval Medical Center
Portsmouth, Virginia, United States
Pediatric Pulmonary Center/Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Children's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Alfred Hospital
Prahran, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Capital Health and the Governors of the University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Brian Lyttle Professional Corporation
London, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Auckland District Health Board
Auckland, New Zealand
Related Publications (1)
Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest. 2009 May;135(5):1223-1232. doi: 10.1378/chest.08-1421.
PMID: 19420195DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Bresnik, MD, Director, Clinical Research
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Bruce Montgomery, MD
Corus Pharma, Inc.
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
June 1, 2005
First Posted
June 2, 2005
Study Start
May 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
April 21, 2011
Results First Posted
April 21, 2011
Record last verified: 2011-03