Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection
Public ClinicalTrials.gov record NCT01059565. 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
Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects With Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF). Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated, patient-reported outcome tool used to measure health-related quality of life for children and adults with CF. The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety data were collected for both the randomized and open-label phases.
Study identification
- NCT ID
- NCT01059565
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 102 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
- Feb 2010 (Type not available)
- Primary completion
- Sep 2011 (Actual)
- Completion
- Jan 2012 (Actual)
- Last update posted
- Mar 11, 2014
2010 – 2012
United States locations
- U.S. sites
- 34
- U.S. states
- 25
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Phoenix | Arizona | 85016 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Denver | Colorado | 80206 | — |
| Not listed | Hartford | Connecticut | 06102 | — |
| Not listed | Wilmington | Delaware | 19803 | — |
| Not listed | Jacksonville | Florida | 32207 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Glenview | Illinois | 60025 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Worcester | Massachusetts | 01605 | — |
| Not listed | Detroit | Michigan | 48201 | — |
| Not listed | Minneapolis | Minnesota | 55455 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Las Vegas | Nevada | 89107 | — |
| Not listed | Morristown | New Jersey | 07962 | — |
| Not listed | New Brunswick | New Jersey | 08903 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | New Hyde Park | New York | 11040 | — |
| Not listed | Chapel Hill | North Carolina | 27599 | — |
| Not listed | Akron | Ohio | 44308 | — |
| Not listed | Columbus | Ohio | 43205 | — |
| Not listed | Toledo | Ohio | 43606 | — |
| Not listed | Oklahoma City | Oklahoma | 73112 | — |
| Not listed | Portland | Oregon | 97239 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Pittsburgh | Pennsylvania | 15201 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Columbia | South Carolina | 29203 | — |
| Not listed | Richmond | Virginia | 23298 | — |
| Not listed | Morgantown | West Virginia | 26506 | — |
| Not listed | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01059565, 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, 2014 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01059565 live on ClinicalTrials.gov.