XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma

Bronchial Asthma Clinical Trial

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Efficacy and Safety of XC8 in Patients With the Eosinophilic Phenotype of Bronchial Asthma

Status Completed

Clinical Trial Summary

A multicenter, double-blind, randomized, pilot study in parallel groups to assess the efficacy and safety of XC8 at a dose of 100 mg versus placebo over a 12-week treatment period in non-smoking patients with a confirmed bronchial asthma (BA) and the eosinophil blood level 2 times within 1 week interval of ≥ 300 cells/μl.

Study design was developed by Chemlmmune Therapeutics LLC, Russia in cooperation with Eurrus Biotech GmbH, Austria.

Clinical Trial Description

The study consists of 3 periods: screening (2 weeks), treatment period (12 weeks) and follow-up (2 weeks). All eligible patients are randomized into one of two treatment groups in a ratio of 1:1. During the study patients will continue to receive stable doses of inhaled corticosteroids (ICS) with or without the long-acting β2-agonists; when required, patients will receive short-acting β2-agonists.The randomized patients will be stratified by the site, baseline forced expiratory volume (FEV1) in the range of 55 to 70% and 71% to 85%, and therapy of BA (inhaled corticosteroids (ICS) with or without long-acting β2 agonists).

The Study drug is produced by Hennig Arzneimittel GmbH und Co., Germany. ;

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Eosinophilic Asthma
• Pulmonary Eosinophilia

• NCT number: NCT04674137
• Study type: Interventional
• Source: Chemlmmune Therapeutics LLC
• Status: Completed
• Phase: Phase 2
• Start date: December 16, 2020
• Completion date: August 27, 2021