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NCT01059565 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT01059565 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 102 participants.
The verdict
NCT01059565, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG AZLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059565
The ClinicalTrials.gov registry entry for NCT01059565 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01059565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01059565 about?
NCT01059565 is a clinical study titled "Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection". 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 Fi...
What is the current status of trial NCT01059565?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2010-02. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01059565?
The interventions under investigation include: Placebo (DRUG), AZLI (DRUG).
Who is sponsoring clinical trial NCT01059565?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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