XC8 in the Treatment of Patients With Bronchial Asthma
Status:
Completed
Trial end date:
2017-09-27
Target enrollment:
Participant gender:
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).