Colistimethate sodium effective against bronchiectasis and P. aeruginosa infection: Study
According to PROMIS-I data published in the journal of The Lancet Respiratory Medicine showed that individuals with bronchiectasis and Pseudomonas aeruginosa infections may benefit clinically from colistimethate sodium administered via the I-neb adaptive aerosol delivery system. As a result of compromised mucociliary clearance and compromised host immunity, patients with bronchiectasis experience a persistent infection of the airways. An elevated risk of exacerbation and higher airway inflammation are linked to an increased bacterial load in the airway. One of the top priorities in treating people with bronchiectasis is preventing exacerbations.
The most frequent infection found in the airways of bronchiectasis patients is P. aeruginosa. More airway inflammation, more severe symptoms and lung function, an accelerated decline in lung function, more bronchiectasis exacerbations, a higher risk of hospitalization, and a higher mortality rate are all linked to the presence of P. aeruginosa in sputum. Thus, this study examined the safety and effectiveness of inhaling colistimethate sodium for 12 months using the I-neb.
The study involved the trials of twice-daily colistimethate sodium against placebo in hospitals in Argentina, Belgium, Australia, Canada, Germany, France, Greece, Italy, Israel, Netherlands, Poland, New Zealand, Portugal, Switzerland, Spain, the UK and the USA. Individuals with bronchiectasis with P. aeruginosa and a record of at least two exacerbations that require oral antibiotics or one requiring IV antibiotics in the past year were enrolled. Using an interactive online response system, the randomization was carried out and stratified by place and duration of macrolide consumption.
In the PROMIS-I study, a total of 377 patients were randomized at random between June 6, 2017 and April 8, 2020. The colistimethate sodium group experienced a yearly exacerbation rate of 0·58, whereas the placebo group experienced an exacerbation rate of 0·95. In PROMIS-II, 287 patients were randomized at random between February 12, 2018 and October 22, 2021. The effects of COVID-19 pandemic led to the early termination of PROMIS-II. The yearly exacerbation rate did not differ significantly between the colistimethate sodium and placebo groups. Overall, 142 patients experienced adverse events in the colistimethate sodium group when compared to 159 in the placebo group in PROMIS-I, and 123 patients experienced adverse events when compared to 104 in PROMIS-II.
Source:
Haworth, C. S., Shteinberg, M., Winthrop, K., Barker, A., Blasi, F., Dimakou, K., Morgan, L. C., O’Donnell, A. E., Ringshausen, F. C., Sibila, O., Thomson, R. M., Carroll, K. J., Pontenani, F., Castellani, P., & Chalmers, J. D. (2024). 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. In The Lancet Respiratory Medicine (Vol. 12, Issue 10, pp. 787–798). Elsevier BV. https://doi.org/10.1016/s2213-2600(24)00225-x
