Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
Public ClinicalTrials.gov record NCT00104520. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00104520
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 211 participants
Conditions and interventions
Conditions
Interventions
- AZLI 75 mg two times a day (BID)/three times a day (TID) Drug
- Placebo two times a day (BID)/three times a day (TID) Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2005 (Type not available)
- Primary completion
- Sep 2006 (Actual)
- Completion
- Sep 2006 (Actual)
- Last update posted
- Mar 11, 2011
2005 – 2006
United States locations
- U.S. sites
- 56
- U.S. states
- 27
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | — | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | — | — |
| University of California, San Diego | La Jolla | California | — | — |
| Children's Hospital Los Angeles | Los Angeles | California | — | — |
| Kaiser Permanente Medical Care Program | Oakland | California | — | — |
| Children's Hospital, Orange Co. | Orange | California | — | — |
| Stanford University Hospital and Medical Center | Palo Alto | California | — | — |
| UC Davis Medical Center | Sacramento | California | — | — |
| Children's Hospital | Denver | Colorado | — | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | — | — |
| University of Florida Health Sciences Center | Gainesville | Florida | — | — |
| Nemours Children's Clinic, Jacksonville | Jacksonville | Florida | — | — |
| University of Miami School of Medicine | Miami | Florida | — | — |
| Nemours Children's Clinic | Orlando | Florida | — | — |
| Pediatric Pulmonary Associates, Florida | St. Petersburg | Florida | — | — |
| Emory Healthcare | Atlanta | Georgia | — | — |
| Medical College of Georgia | Augusta | Georgia | — | — |
| Children's Memorial Hospital/Northwestern University | Chicago | Illinois | — | — |
| Chicago Children's Asthma Respiratory and Exercise Specialists | Glenview | Illinois | — | — |
| Loyola University Medical Center | Maywood | Illinois | — | — |
| North Suburban Pulmonary / Critical Care Consultants | Niles | Illinois | — | — |
| Indiana University | Indianapolis | Indiana | — | — |
| University of Kansas Medical Center | Kansas City | Kansas | — | — |
| Maine Medical Center | Portland | Maine | — | — |
| Children's Hospital, Boston | Boston | Massachusetts | — | — |
| Floating Hospital for Children | Boston | Massachusetts | — | — |
| Massachusetts General Hospital | Boston | Massachusetts | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| Children's Hospital of Michigan/Wayne State University | Detroit | Michigan | — | — |
| University of Minnesota | Minneapolis | Minnesota | — | — |
| Children's Lung Specialists, Ltd. | Las Vegas | Nevada | — | — |
| Morristown Memorial Hospital | Morristown | New Jersey | — | — |
| Albany Medical College | Albany | New York | — | — |
| Long Island College Hospital | Brooklyn | New York | — | — |
| Children's Hospital of Buffalo | Buffalo | New York | — | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | — | — |
| Columbia University Medical Center | New York | New York | — | — |
| State University of New York Stony Brook | Stony Brook | New York | — | — |
| Children's Hospital of Westchester Medical Center/New York Medical College | Valhalla | New York | — | — |
| Akron Children's Hospital | Akron | Ohio | — | — |
| Columbus Children's Hospital, Ohio State University | Columbus | Ohio | — | — |
| Children's Medical Center | Dayton | Ohio | — | — |
| Dr. Santiago Reyes | Oklahoma City | Oklahoma | — | — |
| Oregon Health & Science University | Portland | Oregon | — | — |
| Penn State University Hershey Medical Center | Hershey | Pennsylvania | — | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | — | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | — | — |
| Children's Hospital of Pittsburg | Pittsburgh | Pennsylvania | — | — |
| Rhode Island Hospital | Providence | Rhode Island | — | — |
| Medical University of South Carolina | Charleston | South Carolina | — | — |
| Pediatric Pulmonary Associates, South Carolina | Columbia | South Carolina | — | — |
| Baylor College of Medicine | Houston | Texas | — | — |
| Alamo Clinical Research Associates | San Antonio | Texas | — | — |
| Pediatric Pulmonary Center | Richmond | Virginia | — | — |
| Children's Hospital and Regional Medical Center | Seattle | Washington | — | — |
| West Virginia University | Morgantown | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00104520, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2011 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00104520 live on ClinicalTrials.gov.