Back to resultsSafety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Primary Purpose
Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AZLI 75 mg three times daily (TID)
Placebo three times daily (TID)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, pseudomonas aeruginosa, lung infection, CFQ-R, inhaled antibiotic, aztreonam lysine
Eligibility Criteria
Inclusion Criteria:
- Participants ≥ 6 years of age
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 investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever was longer)
- 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
Sites / Locations
- Phoenix Children's Hospital
- University Medical Center
- Arkansas Children's Hospital
- University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine
- Kaiser Permanente
- Children's Hospital of Orange County
- The Children's Hospital
- Connecticut Children's Medical Center
- Nemours Children's Clinic
- Nemours Children's Clinic
- Children's Memorial Hospital
- Indiana University, Outpatient Clinical Research Facility
- James Whitcomb Riley Hospital for Children
- Children's Hospital, Boston
- Tufts Medical Center, Pediatric Pulmonary Clinic
- University of Michigan Health System
- The Children's Hospital of Michigan, Detroit Medical Center
- The Minnesota CF Center, University of Minnesota Medical Center
- Children's Lung Specialists
- Albany Medical College
- The Lung & Cystic Fibrosis Center, University of Buffalo Pediatric Associates, Inc., Women & Children's Hospital of Buffalo
- Long Island Jewish Medical Center
- SUNY Upstate Medical University
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's Hospital
- Toledo Children's Hospital/Toledo Hospital, Cystic Fibrosis Research Center
- Santiago Reyes, MD
- Penn State Milton S. Hershey Medical Center
- Drexel University College of Medicine, Pulmonary Associates
- Penn Presbyterian Medical Center
- St. Christopher's Hospital for Children
- Baylor College of Medicine
- Primary Children's Medical Center
- Children's Hospital and Regional Medical Center
- Department of Respiratory Medicine, The Children's Hospital at Westmead
- Department of Respiratory Medicine, Westmead Hospital
- The Prince Charles Hospital, Adult Cystic Fibrosis Centre
- Respiratory Medicine, Royal Children's Hospital
- Child and Adolescent Health Services, Princess Margaret Hospital
- Centre de Recherche du CHUM
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo three times daily (TID)
AZLI 75 mg three times daily (TID)
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Secondary Outcome Measures
Change From Baseline in CFQ-R RSS Score at Day 14
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Change From Baseline in CFQ-R RSS Score at Day 42
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Change From Baseline in CFQ-R Physical Functioning Domain Score
The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study
The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher's Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.
Number of Participants Hospitalized During Study
Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.
Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28
Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00712166
Brief Title
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
Acronym
AIR-CF4
Official Title
A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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), mild lung disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas aeruginosa (PA) infection.
Detailed Description
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer, in CF patients with PA and mild lung disease.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
Keywords
cystic fibrosis, pseudomonas aeruginosa, lung infection, CFQ-R, inhaled antibiotic, aztreonam lysine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo three times daily (TID)
Arm Type
Placebo Comparator
Arm Title
AZLI 75 mg three times daily (TID)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AZLI 75 mg three times daily (TID)
Intervention Type
Drug
Intervention Name(s)
Placebo three times daily (TID)
Primary Outcome Measure Information:
Title
Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28
Description
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Time Frame
Day 0 to Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in CFQ-R RSS Score at Day 14
Description
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Time Frame
Day 0 to Day 14
Title
Change From Baseline in CFQ-R RSS Score at Day 42
Description
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Time Frame
Day 0 to Day 42
Title
Change From Baseline in CFQ-R Physical Functioning Domain Score
Description
The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Time Frame
Day 0 to Day 28
Title
Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study
Description
The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher's Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.
Time Frame
Day 0 to Day 42
Title
Number of Participants Hospitalized During Study
Description
Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.
Time Frame
Day 0 to Day 42
Title
Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28
Description
Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Time Frame
Day 0 to Day 28
Title
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
Description
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Time Frame
Day 0 to Day 28
Other Pre-specified Outcome Measures:
Title
Number of Participants Testing Positive for Other Respiratory Pathogens
Description
Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism.
Time Frame
Day 0 to Day 28
Title
The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)
Description
Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group.
Time Frame
Day 0 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants ≥ 6 years of age
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 investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever was longer)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Wainwright, MD
Organizational Affiliation
Royal Children's Hospital, Brisbane, QLD, Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron Gibson, MD
Organizational Affiliation
Children's Hospital & Regional Medical Center, Seattle WA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Kaiser Permanente
City
Oakland
State/Province
California
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
Country
United States
Facility Name
The Children's Hospital
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Nemours Children's Clinic
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University, Outpatient Clinical Research Facility
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
James Whitcomb Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Children's Hospital, Boston
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Tufts Medical Center, Pediatric Pulmonary Clinic
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
The Children's Hospital of Michigan, Detroit Medical Center
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
The Minnesota CF Center, University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Children's Lung Specialists
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
Country
United States
Facility Name
The Lung & Cystic Fibrosis Center, University of Buffalo Pediatric Associates, Inc., Women & Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Toledo Children's Hospital/Toledo Hospital, Cystic Fibrosis Research Center
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Santiago Reyes, MD
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Drexel University College of Medicine, Pulmonary Associates
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Children's Hospital and Regional Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Department of Respiratory Medicine, The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Department of Respiratory Medicine, Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
The Prince Charles Hospital, Adult Cystic Fibrosis Centre
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
Respiratory Medicine, Royal Children's Hospital
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Child and Adolescent Health Services, Princess Margaret Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Centre de Recherche du CHUM
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21441078
Citation
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.
Results Reference
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Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
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