Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
Public ClinicalTrials.gov record NCT01641822. 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, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.
Study identification
- NCT ID
- NCT01641822
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 107 participants
Conditions and interventions
Conditions
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
- Dec 2012 (Type not available)
- Primary completion
- Jan 2015 (Actual)
- Completion
- Jan 2015 (Actual)
- Last update posted
- May 9, 2016
2012 – 2015
United States locations
- U.S. sites
- 71
- U.S. states
- 35
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| University of California - San Diego | La Jolla | California | 92093 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Kaiser Permanente Medical Center | Oakland | California | 94611 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Central Florida Pulmonary Group | Altamonte Springs | Florida | 32701 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| South Broward Hospital dba Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32801 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Nemour's Children's Clinic | Pensacola | Florida | 32504 | — |
| All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Emory Cystic Fibrosis Center | Atlanta | Georgia | 30084 | — |
| Georgia Health | Augusta | Georgia | 30912 | — |
| St. Lukes Medical Center | Boise | Idaho | 37012 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure | Glenview | Illinois | 60025 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Maine Medical Center | Portland | Maine | 38103 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Harper University Hospital | Detroit | Michigan | 48201 | — |
| Spectrum Health - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| St. Louis University - Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Children's Lung Specialists | Las Vegas | Nevada | 89107 | — |
| Dartmouth Hitchcock Specialty Care Clinic | Bedford | New Hampshire | 03110 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| UNM Clinical and Translational Center | Albuquerque | New Mexico | 87131 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center | New Hyde Park | New York | 11042 | — |
| Gunnar Esiason Adult CF and Lung Program | New York | New York | 10032 | — |
| SUNY Upstate University | Syracuse | New York | 13210 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| UC Health - University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| The Toledo Hospital/Toledo Children's Hospital CF Center | Toledo | Ohio | 43606 | — |
| OU Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Santiago Reyes, MD | Oklahoma City | Oklahoma | 73112 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19107 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Children's Foundation Research Institute/UTHSC | Memphis | Tennessee | 28103 | — |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | — |
| Austin Children's Chest Associates | Austin | Texas | 78723 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Alamo Clinical Research Associates | San Antonio | Texas | 78212 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Vermont Lung Center at the University of Vermont | Colchester | Vermont | 05446 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23510 | — |
| VCU Children's Hospital | Richmond | Virginia | 23298 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
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 NCT01641822, 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 May 9, 2016 · 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 NCT01641822 live on ClinicalTrials.gov.