Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)

Summary

The objective of the trial was to investigate the effect of the use of inhaled CMS, administered b.i.d. via a specific nebuliser for 12 months, compared to placebo in subjects with NCFB chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.

Timeline

Start

2017-06-06

Primary completion

2021-04-09

Completion

2021-04-09

Outcome

Met primary endpoint

registry analysis (superiority test); CMS (Colistimethate Sodium) vs Placebo; p = 0.00101; LS Mean rate ratio 0.612 (95% CI 0.457 to 0.820); two-sided Wald chi-square test NCT03093974 ↗

Drugs

Indications