Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
NCT ID: NCT00712166
Last Updated: 2010-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2008-05-31
2009-08-31
Brief Summary
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Detailed Description
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In this study, participant eligibility was assessed at a screening visit that occurred up to 14 days prior to the baseline visit (Day 0). Those participants who met eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow up visit 14 days after the last dose of the trial drug (Day 42).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo three times daily (TID)
Placebo three times daily (TID)
AZLI 75 mg three times daily (TID)
AZLI 75 mg three times daily (TID)
Interventions
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AZLI 75 mg three times daily (TID)
Placebo three times daily (TID)
Eligibility Criteria
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Inclusion Criteria
* 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 ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
* Two well characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
* Abnormal nasal potential difference
* PA present in expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within the 12 months prior to Visit 1 (one of the previous PA positive cultures must have been no more than 3 months prior to Visit 1)
* FEV1 \> 75% predicted at Visit 1
* Participants must have exhibited two or more of the following chronic and/or intermittent CF symptoms, for a minimum of 28 days prior to randomization and with no worsening of symptoms within 7 days prior to randomization:
* Chest congestion
* Daily cough
* Productive cough
* Wheezing
* Trouble breathing
* Nocturnal wakening due to coughing
* Participants (and parent/guardian as required) had to be able to provide written informed consent/assent prior to any study related procedures
* Females of childbearing potential had to have a negative urine pregnancy test at Visit 1
* Ability to perform reproducible pulmonary function tests
* In the opinion of the Investigator, the participant did not require immediate antipseudomonal antibiotic intervention to treat an impending exacerbation, and the participant's condition was stable enough to enroll in the study
Exclusion Criteria
* Administration of any IV, oral, or inhaled antipseudomonal antibiotic within 28 days prior to Visit 1
* Known local or systemic hypersensitivity to monobactam antibiotics
* Inability to tolerate short-acting bronchodilator (BD) use at least TID
* Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
* Changes in or initiation of chronic hypertonic saline treatment within 28 days prior to Visit 1
* Changes in or initiation of dornase alfa within 28 days prior to Visit 1
* Changes in antimicrobial, BD, or corticosteroid medications within 7 days prior to Visit 1
* Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
* History of lung transplantation
* History of participation (enrollment) in any prior clinical studies with AZLI
* A chest radiograph at Visit 1 (or within the previous 180 days of Visit 1), with abnormalities indicating a significant acute finding (e.g., lobar infiltrate and atelectasis, pneumothorax, or pleural effusion); a chest radiograph obtained and interpreted between Visits 1 and 2 was also acceptable for determining eligibility
* Positive urine pregnancy test at Visit 1; all women of childbearing potential were to be tested
* Females of childbearing potential who were lactating or were not (in the opinion of the investigator) practicing an acceptable method of birth control; female participants who utilized hormonal contraceptives as their birth control method must have used the same method for at least 3 months before study dosing
* Participant was being assessed at Visit 1 by the investigator for an acute change in respiratory symptoms
* 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
6 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences, Inc.
Principal Investigators
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Claire Wainwright, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Children's Hospital, Brisbane, QLD, Australia
Ron Gibson, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital & Regional Medical Center, Seattle WA, USA
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
University Medical Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine
Little Rock, Arkansas, United States
Kaiser Permanente
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
The Children's Hospital
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Indiana University, Outpatient Clinical Research Facility
Indianapolis, Indiana, United States
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Hospital, Boston
Boston, Massachusetts, United States
Tufts Medical Center, Pediatric Pulmonary Clinic
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
The Children's Hospital of Michigan, Detroit Medical Center
Detroit, Michigan, United States
The Minnesota CF Center, University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Children's Lung Specialists
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
The Lung & Cystic Fibrosis Center, University of Buffalo Pediatric Associates, Inc., Women & Children's Hospital of Buffalo
Buffalo, 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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Toledo Children's Hospital/Toledo Hospital, Cystic Fibrosis Research Center
Toledo, Ohio, United States
Santiago Reyes, MD
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University College of Medicine, Pulmonary Associates
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Department of Respiratory Medicine, The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Department of Respiratory Medicine, Westmead Hospital
Westmead, New South Wales, Australia
The Prince Charles Hospital, Adult Cystic Fibrosis Centre
Chermside, Queensland, Australia
Respiratory Medicine, Royal Children's Hospital
Herston, Queensland, Australia
Child and Adolescent Health Services, Princess Margaret Hospital
Perth, Western Australia, Australia
Centre de Recherche du CHUM
Montreal, Quebec, Canada
Countries
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References
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Wainwright CE, Quittner AL, Geller DE, Nakamura C, Wooldridge JL, Gibson RL, Lewis S, Montgomery AB. Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. J Cyst Fibros. 2011 Jul;10(4):234-42. doi: 10.1016/j.jcf.2011.02.007. Epub 2011 Mar 26.
Other Identifiers
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GS-US-205-0117
Identifier Type: -
Identifier Source: org_study_id