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
Overview
- Phase
- Phase 2
- Intervention
- XC8 100 mg
- Conditions
- Bronchial Asthma
- Sponsor
- Chemlmmune Therapeutics LLC
- Enrollment
- 70
- Locations
- 18
- Primary Endpoint
- Rate of achieving the minimal clinically significant absolute change in FEV1 (+200 mL)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form;
- •Male and female non-smokers of 18 to 65 years of age (inclusive);
- •The diagnosis of asthma not earlier than 12 months prior to screening;
- •Steps 2 and 3 according to Global Initiative for Asthma (GINA, 2019) recommendations;
- •Patients receiving stable ICS doses with or without long-acting β2-agonists;
- •Еosinophil blood level measured twice at a 1 week interval, of ≥ 300 cells/µl ;
- •Signs of partially controlled BA within 4 weeks prior to screening according to GINA 2019 recommendations;
- •FEV1 value prior to the use of bronchodilators in the range of 55 to 85% of the proper value (inclusive);
- •Consent of patients to use adequate contraception methods throughout the study;
- •Ability to comply with all the study protocol requirements.
Exclusion Criteria
- •Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of child-bearing potential (including those without history of surgical sterilization and women with \<2 years post-menopause) not using adequate contraception methods;
- •Smoking for 1 year prior to screening or previous smoking history of more than 10 packs/year;
- •Severe exacerbations or uncontrolled BA within 3 months prior to screening;
- •Chronic obstructive pulmonary disease (COPD) or other serious lung diseases other than asthma;
- •Inflammatory diseases of the oral cavity at screening;
- •An acute infectious disease within 30 days prior to screening;
- •Participation in any clinical study or any study drug administration within 30 days prior to screening;
- •Taking or indications for taking of prohibited drugs (including anti-leukotriene preparations, modified-release theophylline, etc.);
- •Indications for long-term use of systemic steroids or nonsteroidal anti-inflammatory drugs or drugs affecting on the immune system;
- •The need for periodical intake of antihistamines during the study (stable doses of antihistamines for at least 1 month prior to screening and throughout the study is allowed);
Arms & Interventions
XC8 100 mg
XC8 100 mg orally
Intervention: XC8 100 mg
Placebo
Placebo orally
Intervention: Placebo
Outcomes
Primary Outcomes
Rate of achieving the minimal clinically significant absolute change in FEV1 (+200 mL)
Time Frame: Week 0 - Week 12
To assess the rate of achieving minimal clinically significant absolute change in FEV1 measured in mL compared to baseline through spirometry testing.
Secondary Outcomes
- Changes in FEV1 (in mL)(Week 0 - Week 12)
- Rate of exacerbations of BA(Week 0 - Week 12)
- Change in the Asthma Control Questionnaire 7 (ACQ-7) scores(Week 0 - Week 12)
- Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Week 0 - Week 14)
- Change in FEV1/FVC (in % of predicted)(Week 0 - Week 12)
- Change in forced expiratory flow (FEF) 25-75% (in % of predicted)(Week 0 - Week 12)
- Changes in FEV1 (in % of predicted)(Week 0 - Week 12)
- Change in forced vital capacity of lungs (FVC) in % of predicted(Week 0 - Week 12)
- Change in Peak Expiratory Flow (PEF) Rate(Week 0 - Week 12)