CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 211 enrolled
Drug / intervention
AZLI 75 mg two times a day (BID)/three times a day (TID) +1 moredrug
Likely dose
Aztreonam lysinate 75 mg two or three times daily by inhalationAI-extracted
Key inclusion· 6
  • ✓Confirmed cystic fibrosis diagnosis by sweat chloride ≥60 mEq/L, CFTR gene mutations, or abnormal nasal potential difference with CF symptoms
  • ✓Pseudomonas aeruginosa documented in expectorated sputum or throat swab culture at screening
  • ✓Three or more courses of IV antibiotics (TIS) within the previous 12 months
  • ✓FEV1 between 25% and 75% predicted at screening
Key exclusion· 9
  • ✕Oral corticosteroids exceeding 10 mg prednisone daily or 20 mg every other day
  • ✕History of Burkholderia cepacia in sputum or throat culture within past 2 years
  • ✕History of daily continuous oxygen supplementation or requirement for >2 liters/minute at night
  • ✕Known hypersensitivity to monobactam antibiotics

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

Search/NCT00104520
NCT00104520Phase 3Completed
CompareCT.gov

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)

Gilead Sciences·interventional·Posted Mar 2, 2005·Updated Mar 11, 2011

In Brief

A Phase 3 clinical trial evaluating AZLI 75 mg two times a day (BID)/three times a day (TID) and Placebo two times a day (BID)/three times a day (TID) for Cystic Fibrosis. Completed, enrolled 211 participants across 56 sites.

Detailed Summary

The purpose of this study was to evaluate the safety and efficacy 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
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2, 2005
Enrollment StartFeb 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.3 years ago

Interventions

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

Placebo two times a day (BID)/three times a day (TID)drug