Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
Summary
The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.
Timeline
- Start
- 2018-01-29
- Primary completion
- 2022-03-15
- Completion
- 2022-03-15
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was brought to an early close in March 2022 due to major ongoing recruitment issues primarily related to the COVID-19 pandemic and concerns regarding the continued randomization and exposure of subjects to placebo in the study.”
registry analysis (superiority test); CMS (Colistimethate Sodium) vs Placebo; p = 0.97889; LS Mean rate ratio 1.004 (95% CI 0.747 to 1.349); negative binomial model NCT03460704 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colistimethate sodium | Unknown | 24 mg | Inhaled |