drugset / Trial / NCT03460704

Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.

NCT03460704

Phase 3 Terminated 287 enrolled Zambon SpA
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.

Timeline

Start
2018-01-29
Primary completion
2022-03-15
Completion
2022-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Colistimethate Unknown 24 mg Inhaled

Indications