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NCT01641822 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT01641822 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 107 participants.
The verdict
NCT01641822, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Tobramycin inhalation solution
- DRUG AZLI
- DRUG Placebo to match AZLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641822
The ClinicalTrials.gov registry entry for NCT01641822 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 107 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 3 interventions - of which Tobramycin inhalation solution is the first listed.
NCT01641822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01641822 about?
NCT01641822 is a clinical study titled "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". 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. Participan...
What is the current status of trial NCT01641822?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2012-12. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01641822?
The interventions under investigation include: Tobramycin inhalation solution (DRUG), AZLI (DRUG), Placebo to match AZLI (DRUG).
Who is sponsoring clinical trial NCT01641822?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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