Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI

Summary

The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute respiratory viral infections. This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 study.

Timeline

Start

2018-11-07

Primary completion

2019-02-26

Completion

2019-12-10

Outcome

Missed primary endpoint

registry Mean Difference (Final Values) -0.22 (95% CI -0.6 to 0.16) NCT03840135 ↗

Publications

• Results Garashchenko TI, Karneeva OV, Tarasova GT, Kim IA, Hanferian RA (2020) Efficacy and safety of azoximer bromide (Polyoxidonium) in children aged from 1 to 12 years with ARI: The results of a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group study. Pediatr Dimensions 5: DOI: 10.15761/PD.1000204.

Drugs

Indications