XC8 in the Treatment of Patients With Bronchial Asthma

Summary

A multicenter, double-blind, randomized, parallel-group comparative Phase II clinical study to assess the efficacy and safety of different doses of XC8 vs Placebo in patients with partly controlled bronchial asthma receiving stable treatment with low doses of inhaled corticosteroids with or without long-acting beta2-agonists during 12-weeks treatment period. Study design was developed by Pharmenterprises LLS, Russia in cooperation with Eurrus Biotech GmbH, Austria and FGK Clinical Research GmbH, Germany. The primary objective of the study was to evaluate the effect of different doses of XC8 on change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (% of predicted value) at Week 12 as compared to baseline at Week 0 vs. Placebo in patients with partly controlled bronchial asthma (BA).

Timeline

Start

2016-09-20

Primary completion

2017-09-27

Completion

2017-09-27

Outcome

Missed primary endpoint

paper The primary endpoint, improvement of forced expiratory volume in 1 s (FEV1) % predicted over 12 weeks compared to placebo, was not statistically significant. PMID 33095411 ↗

Publications

• Romanova J, Chikina E, Rydlovskaya A, Pohl W, Renner A, Zeifman A, Chuchalin A, Nebolsin V. New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial. Pulm Ther. 2020 Dec;6(2):351-369. doi: 10.1007/s41030-020-00134-5. Epub 2020 Oct 23.

Drugs

Indications