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NCT00112359 · ClinicalTrials.gov registry record · Phase 3

International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
166
Enrollment target

NCT00112359 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 166 participants.

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The verdict

NCT00112359, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
166 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Interventions

  • DRUG AZLI 75 mg three times a day (TID)
  • DRUG Placebo three times a day (TID)

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2005-05
Est. Completion 2007-04
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT00112359

The ClinicalTrials.gov registry entry for NCT00112359 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 166 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 AZLI 75 mg three times a day (TID) is the first listed.

NCT00112359 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00112359 about?

NCT00112359 is a clinical study titled "International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa". The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

What is the current status of trial NCT00112359?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2005-05. Estimated completion is 2007-04.

What interventions are being tested in trial NCT00112359?

The interventions under investigation include: AZLI 75 mg three times a day (TID) (DRUG), Placebo three times a day (TID) (DRUG).

Who is sponsoring clinical trial NCT00112359?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.