drugset

drugset / Trial / NCT02894684

Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis

NCT02894684 ↗

Phase 4 Completed 16 enrolled Liverpool Heart and Chest Hospital NHS Foundation Trust University of Liverpool · collab

RandomizedCrossoverOpen-labelTreatment

Summary

This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.

Timeline

Start: 2017-01
Primary completion: 2019-02
Completion: 2019-09

Publications

Frost F, Young GR, Wright L, Miah N, Smith DL, Winstanley C, Walshaw MJ, Fothergill JL, Nazareth D. The clinical and microbiological utility of inhaled aztreonam lysine for the treatment of acute pulmonary exacerbations of cystic fibrosis: An open-label randomised crossover study (AZTEC-CF). J Cyst Fibros. 2021 Nov;20(6):994-1002. doi: 10.1016/j.jcf.2020.12.012. Epub 2021 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aztreonam	Small molecule	75 mg	Inhaled
Background	Amoxicillin	Other / unclassified	—	Intravenous
Background	Ceftazidime	Small molecule	—	Intravenous
Background	Colistin	Other / unclassified	—	Intravenous
Background	Fosfomycin	Small molecule	—	Intravenous
Background	Meropenem	Small molecule	—	Intravenous

Indications