Bronchial AsthmaPhase 2NCT04674137
XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma
A Phase 2 study testing XC8 100 mg in people with Bronchial Asthma and Eosinophilic Asthma, run by Chemlmmune Therapeutics LLC at 18 sites in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial Asthma, Eosinophilic Asthma
- What is being tested?
- XC8 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 18 sitesRussia
- Study dates
- 16 Dec 2020to 27 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
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- 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.
Who cannot join
- 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;
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- 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);
- Immunosuppressant therapy within 3 months prior to screening;
- Anaphylaxis, generalized urticaria, or angioedema within 1 year prior to screening;
- Known allergies, hypersensitivity or contraindications for XC8 or its ingredients;
- A history of systemic autoimmune diseases or vascular collagenosis;
- Malignancies within the last 5 years (except for the cured basal cell carcinoma);
- Significant cardiovascular diseases diagnosed at present or within 12 months prior to screening; uncontrolled hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg; pulmonary embolism or deep vein thrombosis;
- Nephrotic syndrome, moderate to severe chronic renal failure or significant renal impairment with creatinine level >1.5 mg/dL (132 μM/l) in males and > 1.4 mg/dL (123 μM/l) in females or glomerular filtration rate < 60 mL/min;
- HIV, hepatitis B or C, history of cirrhosis; 3-fold increased serum aspartate aminotransferase or alanine aminotransferase > above the Upper Limit of Normal; 2-fold increased total bilirubin level > above at screening;
- Anemia (hemoglobin level ≤ 10.5 g/dL in females or ≤ 11.5 g/dL in males); significant blood loss or collection of at least one volumetric unit of donated blood (> 500 mL), or blood transfusion within 12 weeks prior to screening;
- Any concomitant disease, other than asthma, not controlled by a stable therapy regimen;
- Drugs or alcohol abuse at screening or in the past, which, in the Investigator's opinion, makes the patient not eligible for participation in the study;
- Inability to read or write; unwillingness to understand and comply with the protocol procedures; non-compliance with the drug dosing regimen or procedures which, in the Investigator's opinion, may affect study results or the patient's safety and prevent the patient's participation in the study; any other concomitant diseases or severe mental disorders, which make the patient ineligible for participation in the study, limit the legal basis for Informed Consent procedure, or may affect the patient's ability to participate in the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Federal State Autonomous Educational Institution of Higher Education "Immanuel Kant Baltic Federal University"of Ministry of Health of the Russian Federation
Kaliningrad, 236016
Federal State Autonomous Educational Institution of Higher Education "Kazan (Volga region) Federal University"
Kazan', 420008
Federal State Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
Kazan', 420012
State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital n.a. D.D.Pletnev" of the Moscow Department of Healthcare"
Moscow, 105077
State Budgetary Institution of Healthcare of Moscow "City Clinical Hospital No. 52" of the Moscow Department of Healthcare
Moscow, 123182
Federal State Educational Institution of Higher Education "Moscow State University of Medicine and Dentistry n.a.A.I.Yevdokimov" of Ministry of Health of the Russian Federation
Moscow, 127473
State Budgetary Health Institution Republic of Karelia "Republican Hospital named V.A.Baranov"
Petrozavodsk, 185019
JSC "Polyclinic complex"
Saint Petersburg, 190013
State Budgetary Institution of Healthcare "Leningrad region Clinical Hospital"
Saint Petersburg, 194291
LLC "Medical Center" Reavita Med St. Petersburg"
Saint Petersburg, 194354
Saint Petersburg State Budgetary Institution of Healthcare "City polyclinic №117"
Saint Petersburg, 194358
Saint Petersburg State Budgetary Institution of Healthcare St. Martyr Elizabeth City Hospital"
Saint Petersburg, 195257
LLS Research Center for Eco-Security
Saint Petersburg, 196143
Federal State Autonomous Educational Institution of Higher Education "Pavlov First Saint Petersburg State Medical University"of the Ministry of Health of the Russian Federation
Saint Petersburg, 197022
LLS "Mayle"
Saint Petersburg, 199406
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053
LLS diagnostic clinic "Konstanta"
Yaroslavl, 150003
State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov" of Ministry of Health of the Russian Federation
Yaroslavl, 150003
About this study
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
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.
Read the 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.
- Conditions
- Bronchial Asthma, Eosinophilic Asthma
- Being tested
- XC8 100 mg, Placebo
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC8 100 mgDrug
Also called Histamine glutarimide
1 tablet of XC8 100 mg once daily in the morning during 12 weeks of treatment period.
PlaceboDrug
1 tablet of placebo once daily in the morning during 12 weeks of treatment period.
| Study group | Role | What they receive |
|---|---|---|
| XC8 100 mg | Experimental | XC8 100 mg orally Receives: Drug: XC8 100 mg |
| Placebo | Placebo comparator | Placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of achieving the minimal clinically significant absolute change in FEV1 (+200 mL)
To assess the rate of achieving minimal clinically significant absolute change in FEV1 measured in mL compared to baseline through spirometry testing.
Measured: Week 0 - Week 12
Secondary outcomes (9)
Changes in FEV1 (in mL)
To assess relative and absolute changes in FEV1 prior to the use of bronchodilators (in mL)
Measured: Week 0 - Week 12
Changes in FEV1 (in % of predicted)
To assess relative and absolute changes in FEV1 prior to the use of bronchodilators (in % of predicted value)
Measured: Week 0 - Week 12
Change in Peak Expiratory Flow (PEF) Rate
To assess daily variability of PEF rate measured in the morning and evening
Measured: Week 0 - Week 12
Change in forced vital capacity of lungs (FVC) in % of predicted
To assess changes in FVC measured through spirometry testing
Measured: Week 0 - Week 12
Change in FEV1/FVC (in % of predicted)
To assess changes in FEV1/FVC measured through spirometry testing
Measured: Week 0 - Week 12
Change in forced expiratory flow (FEF) 25-75% (in % of predicted)
To assess changes in FEF 25-75% measured through spirometry testing
Measured: Week 0 - Week 12
Rate of exacerbations of BA
To assess the number of patients with exacerbations of BA by GINA 2019 Criteria
Measured: Week 0 - Week 12
Change in the Asthma Control Questionnaire 7 (ACQ-7) scores
To assess the changes in ACQ-7
Measured: Week 0 - Week 12
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs 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 (medDRA).
Measured: Week 0 - Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start16 Dec 2020
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At Visit 3, Week 0 all patients were randomized into 2 groups in 1:1 ratio (35 patients to group of XC8 100 mg and 35 patients to Placebo group).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemlmmune Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EURRUS Biotech GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674137
- Sponsor's protocol ID
- PULM-XC8-04
- Status last verified
- Sep 2021
- First submitted
- 14 Dec 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04674137
- Acronym / sponsor ID
- PULM-XC8-04
- Conditions
- Bronchial Asthma, Eosinophilic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chemlmmune Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- EURRUS Biotech GmbH
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- At Visit 3, Week 0 all patients were randomized into 2 groups in 1:1 ratio (35 patients to group of XC8 100 mg and 35 patients to Placebo group).
| Arm | Type | Receives |
|---|---|---|
| XC8 100 mg | Experimental | Drug: XC8 100 mgXC8 100 mg orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC8 100 mgAlso: Histamine glutarimide1 tablet of XC8 100 mg once daily in the morning during 12 weeks of treatment period. | Drug | XC8 100 mg |
| Placebo1 tablet of placebo once daily in the morning during 12 weeks of treatment period. | Drug | Placebo |
Primary outcome
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.
9 secondary outcomes
Changes in FEV1 (in mL)
Time frame: Week 0 - Week 12
Changes in FEV1 (in % of predicted)
Time frame: Week 0 - Week 12
Change in Peak Expiratory Flow (PEF) Rate
Time frame: Week 0 - Week 12
Change in forced vital capacity of lungs (FVC) in % of predicted
Time frame: Week 0 - Week 12
Change in FEV1/FVC (in % of predicted)
Time frame: Week 0 - Week 12
Change in forced expiratory flow (FEF) 25-75% (in % of predicted)
Time frame: Week 0 - Week 12
Rate of exacerbations of BA
Time frame: Week 0 - Week 12
Change in the Asthma Control Questionnaire 7 (ACQ-7) scores
Time frame: Week 0 - Week 12
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Week 0 - Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XC8 100 mg in people with Bronchial Asthma and Eosinophilic Asthma, run by Chemlmmune Therapeutics LLC at 18 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of achieving the minimal clinically significant absolute change in FEV1 (+200 mL) (time frame: Week 0 - Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.