A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)
Phase of Trial: Phase III
Latest Information Update: 19 Feb 2019
At a glance
- Drugs Colistimethate sodium (Primary)
- Indications Bronchiectasis; Pseudomonal infections
- Focus Registrational; Therapeutic Use
- Acronyms PROMIS I
- Sponsors Zambon SpA
- 26 Jun 2018 Planned End Date changed from 1 Apr 2019 to 1 Apr 2020.
- 26 Jun 2018 Planned primary completion date changed from 1 Apr 2019 to 1 Apr 2020.
- 22 Jun 2018 Planned number of patients changed from 264 to 464.