CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 274 enrolled
Drug / intervention
AZLI 75 mg two times a day (BID)/ three times a day (TID)drug
Likely dose
Aztreonam lysinate 75 mg two or three times daily by inhalationAI-extracted
Key inclusion· 3
  • ✓Completion of prior CP-AI-005 or CP-AI-007 study or withdrawal due to need for antipseudomonal antibiotics or non-drug-related adverse event
  • ✓At least 50% compliance with study medication in prior trial
  • ✓Ability to perform reproducible pulmonary function tests
Key exclusion· 7
  • ✕Known hypersensitivity or inability to tolerate aztreonam or short-acting beta-2 agonists
  • ✕History of Burkholderia cepacia in sputum or throat culture within prior 2 years
  • ✕Oral corticosteroids exceeding 10 mg prednisone daily or 20 mg every other day
  • ✕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/NCT00128492
NCT00128492Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)

Gilead Sciences·interventional·Posted Aug 10, 2005·Updated May 19, 2011

In Brief

A Phase 3 clinical trial evaluating AZLI 75 mg two times a day (BID)/ three times a day (TID) for Cystic Fibrosis. Completed, enrolled 274 participants across 65 sites in 4 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and efficacy of multiple courses of 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 PostedAug 10, 2005
Enrollment StartAug 1, 2005
Primary CompletionNov 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.9 years ago

Interventions

AZLI 75 mg two times a day (BID)/ three times a day (TID)drug