Bronchial AsthmaPhase 2NCT03450434
XC8 in the Treatment of Patients With Bronchial Asthma
A Phase 2 study testing XC8 Oral Tablet in people with Bronchial Asthma, run by PHARMENTERPRISES LLC at 12 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- XC8 Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 12 sitesRussia
- Study dates
- 20 Sep 2016to 27 Sep 2017
- 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 the informed consent.
- Non-smoking men and women aged from 18 to 65 (inclusively).
- Diagnosis of bronchial asthma that was established not later than 12 months before screening (with mandatory documented evaluation of reversibility of bronchial obstruction assessed by pre- and post-bronchodilator spirometry).
- Stable therapy with low doses of inhaled corticosteroids with or without long-acting beta2-agonists for at least 3 months prior to screening (Step 2 and 3 according to GINA, 2015 guideline)
- Symptoms of partly controlled bronchial asthma during four weeks before screening (accordingly to GINA, 2015)
- Pre-bronchodilator FEV1 is 60-80% of predicted values (inclusive) *
Show all 11Show fewer
- Consent of patient to use adequate methods of contraception throughout the study. The adequate methods of contraception are as follows:
- Oral or transdermal contraceptives;
- Condom or diaphragm (barrier method) with spermicide, or
- Intrauterine device.
- Ability to follow all the requirements of the protocol
Who cannot join
- Pregnant or lactating women or women planning pregnancy during the clinical trial; women of childbearing potential (including not sterilized operatively and in postmenopausal period less than 2 years), not using appropriate methods of contraception
- Smoking within 1 year prior to screening; smoking history of more than 10 pack-year
- Severe exacerbations or not controlled bronchial asthma for 3 months before screening
- Chronic Obstructive Pulmonary Disease (COPD) or other lung diseases in addition to bronchial asthma.
- Inflammatory diseases of mouth
- Acute infection within 30 days of screening
Show all 23Show fewer
- Participation in any clinical trial or use of any investigational product within 30 days of screening
- Use or indication to take other drugs for treatment of asthma (including antileukotrienes and theophylline extended release), except those permitted by the Protocol
- Indication for long-term administration of systemic steroidal or non-steroidal anti-inflammatory agents or agents affecting the immune system
- The need of periodical administration of antihistamines (stable doses of antihistamines for at least 1 month prior to screening and throughout the trial is allowed)
- Administration of immunosuppressant drugs within 3 months before screening
- Anaphylaxis, generalized urticaria or angioedema within 1 year prior to screening
- Known allergy, hypersensitivity or contraindication to receiving XC8 or its components
- Systemic autoimmune diseases or collagen vascular disease in history.
- History of malignancy within the past 5 years (except for basal cell carcinoma)
- Significant cardiac and vascular disease at the present time or for 12 months before screening, including chronic heart failure NYHA Class III or IV; severe arrhythmia requiring therapy with Class Ia, Ib, Ic and Class III antiarrhythmic drug; unstable angina; myocardial infarction; cardiac surgery and CABG; relevant cardiac valves disorders; transient ischemic attack or stroke; uncontrolled arterial hypertension with systolic pressure >180 mm Hg and diastolic pressure >110 mm Hg; pulmonary embolism or deep vein thrombosis.
- Nephrotic syndrome, moderate and severe chronic renal failure, or significant renal diseases with creatinine level of >1.5 mg/dL (132 μmol/L) in men and >1.4 mg/dL (123 μmol/L) in women or Glomerular Filtration Rate (GFR) < 60 ml/min.
- HIV, hepatitis B or C, hepatic cirrhosis in history; elevated level of serum aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 3 times of the upper limit of normal (UNL); elevated common bilirubin ≥ 2 times of UNL at the screening.
- Anemia (hemoglobin ≤10.5 g/dL in women and ≤ 11.5 g/dL in men); marked blood loss or sampling not less than one unit of donated blood (≥ 500 ml) or blood transfusion for previous 12 weeks.
- Any concomitant disease besides bronchial asthma which is not controlled with stable treatment.
- Drug or alcohol abuse at the moment of screening or in past which, at the discretion of the investigator, make the patient unfit for the study
- Inability to read or to write; unwillingness to understand and to follow the procedures of the study protocol; violation of the drug administration regimen or procedure execution that, at the discretion of the Investigator, can impact the results of the study or safety of the patient and interfere his further participation in the study; any other concomitant medical and serious mental conditions which make the patient unfit for participation in the clinical study, limit a validity of receiving of informed consent or can affect ability of the patient to take part in the study
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
"Allergy and Immunology Center" LLC
Krasnodar, 350007
"Pulmonology Research Institute" FMBA of Russia
Moscow, 105077
Central Research Institute for Tuberculosis at Russian Medical Sciences
Moscow, 107564
Moscow State Medical-Dentist University n.a. A.I. Evdokimov on basis of SMHI "City Hospital № 62", branch 5
Moscow, 121552
Russian Medical Academy of postgraduate education of Ministry of Healthcare on basis of city's Clinical Hospital № 52
Moscow, 123995
Ryazan State Medical University
Ryazan, 390005
State Budgetary Institution of Healthcare "Leningrad region Clinical Hospital"
Saint Petersburg, 194291
Saint Petersburg State Monetary Healthcare Institution "Nicolaevskiy Hospital"
Saint Petersburg, 19510
"Medical Researches Institute" LLC
Saint Petersburg, 196084
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053
Federal State Budgetary Educational Institution of the Higher Education "Smolensk State Medical
Smolensk, 214019
State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"
Yaroslavl, 150003
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Optimal Dose of XC8 in Patients With Partly Controlled Bronchial Asthma Receiving Stable Treatment With Low Doses of Inhaled Corticosteroids With or Without Long-acting beta2-agonists
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).
Read the detailed description
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.
- Conditions
- Bronchial Asthma
- Being tested
- XC8 Oral Tablet, Placebo Oral Tablet
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC8 Oral TabletDrug
Also called Histamine glutarimide
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 Oral TabletDrug
Placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
| Study group | Role | What they receive |
|---|---|---|
| XC8 2 mg | Experimental | XC8 2mg orally Receives: Drug: XC8 Oral Tablet |
| XC8 10 mg | Experimental | XC8 10 mg orally Receives: Drug: XC8 Oral Tablet |
| XC8 100 mg | Experimental | XC8 100 mg orally Receives: Drug: XC8 Oral Tablet |
| Placebo | Placebo comparator | Placebo 2 mg, 10 mg or 100 mg orally Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value
To assess changes in FEV1 measured in % through spirometry testing
Measured: Week 0 - Week 12
Secondary outcomes (14)
Change in Peak expiratory flow rate
To assess daily variability of Peak expiratory flow rate measured in the morning and evening
Measured: 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
Measured: Week 0 - Week 12
Change in 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 FEF 25-75% in % of predicted
To assess changes in FEF 25-75% measured through spirometry testing
Measured: 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
Measured: Week 0 - Week 12
Proportion of patients with adequate BA control
To assess number of patients with adequate BA control by GINA 2015 criteria
Measured: 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
Measured: Week 0 - Week 12
Change of eosinophils level in blood and sputum
To assess change of eosinophils level as part of laboratory analysis
Measured: Week 0 - Week 12
Change of serum IgE level
To assess change of serum IgE level as part of laboratory analysis
Measured: Week 0 - Week 12
Change of serum IgG level
To assess change of serum IgG level as part of laboratory analysis
Measured: Week 0 - Week 12
Change of serum eosinophil cationic protein level
To assess change of serum eosinophil cationic protein as part of laboratory analysis
Measured: Screening - Week 0 - Week 12
Change of serum tryptase level
To assess changes of serum tryptase as part of laboratory analysis
Measured: 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
Measured: Week 0 - Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start20 Sep 2016
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2, Week -1 the patients who meet all inclusion/exclusion criteria were included in the single-blind placebo run-in period. At Visit 3, Week 0 all patients were randomized to 4 treatment groups in 1:1:1:1 ratio (30 patients per each group of XC8 2 mg, 10 mg or 100 mg; and 30 patients to Placebo group).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EURRUS Biotech GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450434
- Sponsor's protocol ID
- PULM-XC8-02
- Status last verified
- Feb 2018
- First submitted
- 11 Jan 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romanova J, Chikina E, Rydlovskaya A, Pohl W, Renner A, Zeifman A, Chuchalin A, Nebolsin V. New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial. Pulm Ther. 2020 Dec;6(2):351-369. doi: 10.1007/s41030-020-00134-5. Epub 2020 Oct 23.
PubMed 33095411
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Optimal Dose of XC8 in Patients With Partly Controlled Bronchial Asthma Receiving Stable Treatment With Low Doses of Inhaled Corticosteroids With or Without Long-acting beta2-agonists
- ClinicalTrials.gov ID
- NCT03450434
- Acronym / sponsor ID
- PULM-XC8-02
- Conditions
- Bronchial Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Collaborators
- EURRUS Biotech GmbH
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 1 Mar 2018 (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, 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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- At Visit 2, Week -1 the patients who meet all inclusion/exclusion criteria were included in the single-blind placebo run-in period. At Visit 3, Week 0 all patients were randomized to 4 treatment groups in 1:1:1:1 ratio (30 patients per each group of XC8 2 mg, 10 mg or 100 mg; and 30 patients to Placebo group).
| Arm | Type | Receives |
|---|---|---|
| XC8 2 mg | Experimental | Drug: XC8 Oral TabletXC8 2mg orally |
| XC8 10 mg | Experimental | Drug: XC8 Oral TabletXC8 10 mg orally |
| XC8 100 mg | Experimental | Drug: XC8 Oral TabletXC8 100 mg orally |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo 2 mg, 10 mg or 100 mg orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed the informed consent.
- Non-smoking men and women aged from 18 to 65 (inclusively).
- Diagnosis of bronchial asthma that was established not later than 12 months before screening (with mandatory documented evaluation of reversibility of bronchial obstruction assessed by pre- and post-bronchodilator spirometry).
- Stable therapy with low doses of inhaled corticosteroids with or without long-acting beta2-agonists for at least 3 months prior to screening (Step 2 and 3 according to GINA, 2015 guideline)
- Symptoms of partly controlled bronchial asthma during four weeks before screening (accordingly to GINA, 2015)
Key exclusion criteria (23 listed)
- Pregnant or lactating women or women planning pregnancy during the clinical trial; women of childbearing potential (including not sterilized operatively and in postmenopausal period less than 2 years), not using appropriate methods of contraception
- Smoking within 1 year prior to screening; smoking history of more than 10 pack-year
- Severe exacerbations or not controlled bronchial asthma for 3 months before screening
- Chronic Obstructive Pulmonary Disease (COPD) or other lung diseases in addition to bronchial asthma.
- Inflammatory diseases of mouth
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 Oral TabletAlso: Histamine glutarimide1 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. | Drug | XC8 10 mg, XC8 100 mg, XC8 2 mg |
| Placebo Oral TabletPlacebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period. | Drug | Placebo |
Primary outcome
Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value
Time frame: Week 0 - Week 12
To assess changes in FEV1 measured in % through spirometry testing
14 secondary outcomes
Change in Peak expiratory flow rate
Time frame: Week 0 - Week 12
Change in Forced expiratory volume in 1 second (FEV1) in absolute values
Time frame: Week 0 - Week 12
Change in 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 FEF 25-75% in % of predicted
Time frame: Week 0 - Week 12
Change in frequency of using short-acting β2-agonists
Time frame: Week 0 - Week 12
Proportion of patients with adequate BA control
Time frame: Week 6 and Week 12
Rate of severe exacerbations of BA
Time frame: Week 0 - Week 12
Change of eosinophils level in blood and sputum
Time frame: Week 0 - Week 12
Change of serum IgE level
Time frame: Week 0 - Week 12
Change of serum IgG level
Time frame: Week 0 - Week 12
Change of serum eosinophil cationic protein level
Time frame: Screening - Week 0 - Week 12
Change of serum tryptase level
Time frame: Screening - Week 0 - Week 12
Number of Adverse events and Serious adverse event
Time frame: Week 0 - Week 12
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 1 Mar 2018.
- Derived from this study: PubMed 33095411Romanova J, Chikina E, Rydlovskaya A, Pohl W, Renner A, Zeifman A, Chuchalin A, Nebolsin V. New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial. Pulm Ther. 2020 Dec;6(2):351-369. doi: 10.1007/s41030-020-00134-5. Epub 2020 Oct 23.
- 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.
12 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 Oral Tablet in people with Bronchial Asthma, run by PHARMENTERPRISES LLC at 12 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 11 inclusion and 23 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value (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?
On the ClinicalTrials.gov record for NCT03450434, which also lists 1 linked publication.
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 1 Mar 2018.