XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma (NCT04674137) | Clinical Trial Compass
CompletedPhase 2
XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma
Russia70 participantsStarted 2020-12-16
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of achieving the minimal clinically significant absolute change in FEV1 (+200 mL)
. FEV1 value prior to the use of bronchodilators in the range of 55 to 85% of the proper value (inclusive);
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.);