Home > Pulmonology > ATS 2022 > Colistimethate sodium PROMISing for non-cystic fibrosis bronchiectasis

Colistimethate sodium PROMISing for non-cystic fibrosis bronchiectasis

Presented By
Dr Charles Haworth, Royal Papworth Hospital, UK
Conference
ATS 2022
Trial
Phase 3, PROMIS


In the phase 3 PROMIS clinical program, 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 program (NCT03093974), consisting of the PROMIS-I (n=377) and PROMIS-II (n=287) trials, are both 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. Dr Charles Haworth (Royal Papworth Hospital, UK) presented the results at the Clinical Trials Symposium at ATS 2022 [1].

Twice-daily administration of nebulised colistimethate sodium powder (n=177) significantly reduced annual pulmonary exacerbation rates compared with placebo (n=200) in this population, over the course of the 12-month study (0.58 vs 0.95 per patient per year; rate ratio [RR] 0.61; 95% CI 0.46–0.82; P=0.00101), which was the primary endpoint of the trial. The treatment effect was larger in adherent participants (43.5% reduction in exacerbations; P=0.00080). 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=0.00074). The frequency of severe exacerbations was also reduced (RR 0.41; 95% CI 0.23–0.74; P=0.00300). 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=0.0055). After 28 days of treatment, P. aeruginosa density was significantly reduced in the treatment arm (P<0.00001). The percentage of patients with adverse events was similar between groups. Bronchospasm and antibiotic resistance were infrequently observed (2.8% and 1%, respectively).

“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. Session B12, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.

 

 

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