PROMIS-I
Trial question
What is the role of inhaled colistimethate sodium in patients with bronchiectasis and P. aeruginosa infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
67.0% female
33.0% male
N = 373
373 patients (249 female, 124 male).
Inclusion criteria: patients with bronchiectasis and P. aeruginosa infection.
Key exclusion criteria: bronchiectasis due to cystic fibrosis; current treatment for allergic bronchopulmonary aspergillosis or mycobacterial infection; change in pulmonary treatment in the 30 days before the screening visit; change in treatment between the screening visit and random assignment.
Interventions
N=176 colistimethate sodium (inhaled dose of 0.3 million IU delivered via the I-neb® device BID for up to 12 months).
N=197 placebo (matching placebo via the I-neb® device BID for up to 12 months).
Primary outcome
Annual pulmonary exacerbation rate
0.58
0.95
0.9 episodes
0.7 episodes
0.5 episodes
0.2 episodes
0.0 episodes
Colistimethate
sodium
Placebo
Significant
decrease ▼
Significant decrease in annual pulmonary exacerbation rate (0.58 episodes vs. 0.95 episodes; RR 0.61, 95% CI 0.46 to 0.82).
Secondary outcomes
Significantly greater reduction in least square mean P. aeruginosa density at day 28 (1.627 log10/CFU/mL vs. 0.007 log10/CFU/mL; MD 1.62, 95% CI 1.25 to 1.99).
No significant difference in ≥ 1 hospitalization for exacerbation of all patients with at least one exacerbation (23% vs. 26%; RRR 0.63, 95% CI 0.34 to 1.17).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In patients with bronchiectasis and P. aeruginosa infection, colistimethate sodium was superior to placebo with respect to annual pulmonary exacerbation rate.
Reference
Charles S Haworth, Michal Shteinberg, Kevin Winthrop et al. Inhaled colistimethate sodium in patients with bronchiectasis and Pseudomonas aeruginosa infection: results of PROMIS-I and PROMIS-II, two randomised, double-blind, placebo-controlled phase 3 trials assessing safety and efficacy over 12 months. Lancet Respir Med. 2024 Sep 6:S2213-2600(24)00225-X.
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