PROMIS-II
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
69.0% female
31.0% male
N = 287
287 patients (198 female, 89 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=152 colistimethate sodium (inhaled dose of 0.3 million IU delivered via the I-neb® device BID for up to 12 months).
N=135 placebo (matching placebo via the I-neb® device BID for up to 12 months).
Primary outcome
Annual pulmonary exacerbation rate
0.89
0.89
0.9 episodes
0.7 episodes
0.4 episodes
0.2 episodes
0.0 episodes
Colistimethate
sodium
Placebo
No significant
difference ↔
No significant difference in annual pulmonary exacerbation rate (0.89 episodes vs. 0.89 episodes; RR 1, 95% CI 0.75 to 1.35).
Secondary outcomes
No significant difference in median time to first exacerbation (267 days vs. 214 days; HR 0.93, 95% CI 0.67 to 1.28).
Significantly greater reduction in least square mean P. aeruginosa density at day 28 (1.679 log10/CFU/mL vs. 0.081 log10/CFU/mL; MD 1.598, 95% CI 1.22 to 1.98).
No significant difference in ≥ 1 hospitalization for exacerbation of all patients with at least one exacerbation (17% vs. 16%; RR 1.01, 95% CI 0.52 to 2.34).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In patients with bronchiectasis and P. aeruginosa infection, colistimethate sodium was not 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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