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A few days ago, Zambon announced that it will use its I-neb adaptive inhalation aerosol delivery system to deliver CMS sodium, a phase 3 clinical trial PROMIS-I in non-cystic fibrosis bronchiectasis (NCFB) patients.
The primary end point was reached
.
Compared with placebo, the annual incidence of acute exacerbations in NCFB patients in the CMS I-neb group was significantly reduced (0.
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic lung disease characterized by repeated infections, inflammations, persistent coughing and sputum production.
Its prevalence is on the rise worldwide
.
Among NCFB patients, Pseudomonas aeruginosa (Pseudomonas aeruginosa) lung infection is associated with frequent acute exacerbations of the disease and hospital admissions, reduced quality of life, and increased mortality
CMS is a prodrug of the antibiotic colistin.
As a surfactant, it works by binding to the bacterial cell membrane and changing its permeability, causing bacterial death
.
I-neb is the third generation nebulizer for adaptive aerosol delivery (AAD)
A total of 377 patients were enrolled in the trial, and they were randomized to receive CMS I-neb (n=177) or placebo (n=200)
.
The results of the trial showed that in addition to the primary endpoint, the trial also reached important secondary endpoints.
In terms of safety, the treatment system is well tolerated
.
The percentages of patients with adverse events were similar in the two groups
Reference materials:
[1] Positive Results from Phase 3 PROMIS-I Study of CMS I-neb® in Patients with Non-Cystic Fibrosis Bronchiectasis Presented at European Respiratory Society (ERS) Annual Meeting.
(The original text has been deleted)
