A Double-blind Placebo-controlled Multi-centre Clinical Trial to Investigate the Efficacy and Safety of 24 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected Wi

Brief description of study

This study aims to obtain information on the efficacy and safety of a drug called colistimethate sodium in comparison with a placebo, administered twice daily via an I-neb Adaptive Aerosol Delivery (AAD) system, for 12 months in adult patients affected by non-CF bronchiectasis chronically infected by a bacteria named Pseudomonas aeruginosa. Colistimethate sodium is converted in water to “colistin”, which is an antibiotic and which has been used per injection since 1959. It is not currently approved for use in CF or non-CF bronchiectasis patients in the US so it is available only as an investigational drug. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA), but it is available in clinical research studies such as this one. The main purpose of this study is to find out if the study drug reduces the frequency of pulmonary exacerbations in subjects with non-CF bronchiectasis chronically infected with Pseudomonas aeruginosa.


Clinical Study Identifier: s18-00553
ClinicalTrials.gov Identifier: NCT03093974
Principal Investigator: Doreen J Addrizzo-Harris.
Other Investigator: Rany Condos.


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