Colistimethate sodium PROMISing for non-cystic fibrosis bronchiectasis

In the phase 3 PROMIS clinical programme, the use of colistimethate sodium powder for nebulisation solution reduced pulmonary exacerbations in adults with non-cystic fibrosis bronchiectasis (NCFB) and Pseudomonas aeruginosa.

The phase 3 PROMIS clinical programme (NCT03093974), consisting of the PROMIS-I (n=377) and PROMIS-II (n=287) trials, was designed to evaluate the safety and efficacy of colistimethate sodium powder for nebulisation solution in patients with NCFB who are chronically infected with P. aeruginosa [1]. Dr Charles Haworth (Royal Papworth Hospital, UK) presented the results.

After 12 months, twice-daily administration of nebulised colistimethate sodium powder (n=177) significantly reduced annual pulmonary exacerbation rates compared with placebo (n=200; 0.58 vs 0.95 per patient per year; rate ratio [RR] 0.61; 95% CI 0.46–0.82; P=0.001); thus, meeting the primary endpoint of the trial. The treatment effect was larger in adherent participants (43.5% reduction in exacerbations; P<0.001). The trial also met important secondary endpoints, demonstrating improvements compared with placebo regarding prolonged time to first exacerbation in the nebulised colistimethate sodium powder group (HR 0.59; 95% CI 0.43–0.81; P<0.001, see Figure). The frequency of severe exacerbations was also reduced (RR 0.41; 95% CI 0.23–0.74; P=0.003). Quality of life, measured by the St. George’s Respiratory Questionnaire (SGRQ), significantly improved with colistimethate sodium powder, with a 4.55 point difference versus placebo after 12 months of treatment (P=0.006). After 28 days of treatment, P. aeruginosa density was significantly reduced in the treatment arm (P<0.001). The percentage of patients with adverse events was similar between groups. Bronchospasm and antibiotic resistance were infrequently observed (2.8% and 1%, respectively).

Figure: Time to first exacerbation in PROMIS [1]



“The PROMIS data shows that colistimethate sodium powder taken twice daily through nebulisation solution reduces exacerbation frequency and improves quality of life in people with bronchiectasis and chronic P. aeruginosa infection,” summarised Dr Haworth. “The data also demonstrates that 12 months of treatment is well tolerated. These results are encouraging for patients as there is currently no approved drug treatment for this indication.”

1. Haworth C, et al. Efficacy and Safety of Colistimethate Sodium Delivered Via the I-Neb in Patients with Bronchiectasis and Pseudomonas Aeruginosa. Session B12, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.

 

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Posted on 18 July 2022