CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 166 enrolled
Drug / intervention
AZLI 75 mg three times a day (TID) +1 moredrug
Likely dose
Aztreonam lysinate 75 mg three times a day (TID) inhaledAI-extracted
Key inclusion· 5
  • ✓Documented cystic fibrosis diagnosis confirmed by sweat chloride ≥60 mEq/L, CFTR gene mutations, or abnormal nasal potential difference
  • ✓Pseudomonas aeruginosa present in expectorated sputum or throat swab culture at Screening
  • ✓FEV1 between 25% and 75% predicted at Screening
  • ✓Room air oxygen saturation ≥90% at Screening
Key exclusion· 9
  • ✕Antipseudomonal antibiotics (including azithromycin) by any route within 14 days of Screening
  • ✕Oral corticosteroid dose exceeding 10 mg prednisone/day or 20 mg prednisone every other day
  • ✕Burkholderia cepacia isolated from sputum or throat swab culture within 2 years prior to Screening
  • ✕Daily continuous oxygen supplementation or requirement for >2 liters/minute at night

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112359
NCT00112359Phase 3Completed
CompareCT.gov

A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)

Gilead Sciences·interventional·Posted Jun 2, 2005·Updated Apr 21, 2011

In Brief

A Phase 3 clinical trial evaluating AZLI 75 mg three times a day (TID) and Placebo three times a day (TID) for Cystic Fibrosis. Completed, enrolled 166 participants across 53 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, New Zealand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2, 2005
Enrollment StartMay 1, 2005
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 21.1 years ago

Interventions

AZLI 75 mg three times a day (TID)drug

Placebo three times a day (TID)drug