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).
Twenty Russian centers were approved for participation in this study. Twelve centers were initiated. Patients were enrolled in 12 centers. The study consisted of 4 periods: Screening, Run-In Period, Treatment Period, and Follow-up. All eligible patients were randomized into one of four treatment groups in a ratio of 1:1:1:1. Treatment group of XC8 2 mg daily (30 patients) Treatment group of XC8 10 mg daily (30 patients) Treatment group of XC8 100 mg daily (30 patients) Treatment group of Placebo (30 patients) The study drug was manufactured by order Pharmenterprises LLS, Russia and Eurrus Biotech GmbH, Austria. During the treatment period (12 weeks) patients took the study drug or Placebo once a day in addition to stable low doses of Inhaled Corticosteroids (ICS) with or without long-acting beta2-agonists (LABA). The follow-up period lasted for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
1 tablet of XC8 in a dose according to the treatment group + 2 tablets of placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
Placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
"Allergy and Immunology Center" LLC
Krasnodar, Russia
"Pulmonology Research Institute" FMBA of Russia
Moscow, Russia
Central Research Institute for Tuberculosis at Russian Medical Sciences
Moscow, Russia
Moscow State Medical-Dentist University n.a. A.I. Evdokimov on basis of SMHI "City Hospital № 62", branch 5
Moscow, Russia
Russian Medical Academy of postgraduate education of Ministry of Healthcare on basis of city's Clinical Hospital № 52
Moscow, Russia
Ryazan State Medical University
Ryazan, Russia
State Budgetary Institution of Healthcare "Leningrad region Clinical Hospital"
Saint Petersburg, Russia
Saint Petersburg State Monetary Healthcare Institution "Nicolaevskiy Hospital"
Saint Petersburg, Russia
"Medical Researches Institute" LLC
Saint Petersburg, Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, Russia
...and 2 more locations
Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value
To assess changes in FEV1 measured in % through spirometry testing
Time frame: Week 0 - Week 12
Change in Peak expiratory flow rate
To assess daily variability of Peak expiratory flow rate measured in the morning and evening
Time frame: Week 0 - Week 12
Change in Forced expiratory volume in 1 second (FEV1) in absolute values
To assess changes in FEV1 measured through spirometry testing
Time frame: Week 0 - Week 12
Change in FVC in % of predicted
To assess changes in FVC measured through spirometry testing
Time frame: Week 0 - Week 12
Change in FEV1/FVC in % of predicted
To assess changes in FEV1/FVC measured through spirometry testing
Time frame: Week 0 - Week 12
Change in FEF 25-75% in % of predicted
To assess changes in FEF 25-75% measured through spirometry testing
Time frame: Week 0 - Week 12
Change in frequency of using short-acting β2-agonists
To assess frequency of using short-acting β2-agonists for resolving BA symptoms recorded in Patient's diary
Time frame: Week 0 - Week 12
Proportion of patients with adequate BA control
To assess number of patients with adequate BA control by GINA 2015 criteria
Time frame: Week 6 and Week 12
Rate of severe exacerbations of BA
To assess number of patients with severe exacerbations of BA by GINA 2015 criteria
Time frame: Week 0 - Week 12
Change of eosinophils level in blood and sputum
To assess change of eosinophils level as part of laboratory analysis
Time frame: Week 0 - Week 12
Change of serum IgE level
To assess change of serum IgE level as part of laboratory analysis
Time frame: Week 0 - Week 12
Change of serum IgG level
To assess change of serum IgG level as part of laboratory analysis
Time frame: Week 0 - Week 12
Change of serum eosinophil cationic protein level
To assess change of serum eosinophil cationic protein as part of laboratory analysis
Time frame: Screening - Week 0 - Week 12
Change of serum tryptase level
To assess changes of serum tryptase as part of laboratory analysis
Time frame: Screening - Week 0 - Week 12
Number of Adverse events and Serious adverse event
Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version. For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects
Time frame: Week 0 - Week 12
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