XC8 in the Treatment of Patients With Bronchial Asthma

NCT03450434 | Completed Phase 2

• 1 other identifier: PULM-XC8-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

Brief 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 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).

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value

  To assess changes in FEV1 measured in % through spirometry testing

  Week 0 - Week 12

Secondary Outcomes (14)

• Change in Peak expiratory flow rate

  Week 0 - Week 12

• Change in Forced expiratory volume in 1 second (FEV1) in absolute values

  Week 0 - Week 12

• Change in FVC in % of predicted

  Week 0 - Week 12

• Change in FEV1/FVC in % of predicted

  Week 0 - Week 12

• Change in FEF 25-75% in % of predicted

  Week 0 - Week 12

Study Arms (4)

XC8 2 mg

EXPERIMENTAL

XC8 2mg orally

Drug: XC8 Oral Tablet

XC8 10 mg

EXPERIMENTAL

XC8 10 mg orally

Drug: XC8 Oral Tablet

XC8 100 mg

EXPERIMENTAL

XC8 100 mg orally

Drug: XC8 Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo 2 mg, 10 mg or 100 mg orally

Drug: Placebo Oral Tablet

Interventions

XC8 Oral Tablet DRUG

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.

Also known as: Histamine glutarimide

XC8 10 mg; XC8 100 mg; XC8 2 mg

Placebo Oral Tablet DRUG

Placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \*
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead
• EURRUS Biotech GmbH: collaborator

Study Sites (12)

"Allergy and Immunology Center" LLC

Krasnodar, 350007, Russia

Location

"Pulmonology Research Institute" FMBA of Russia

Moscow, 105077, Russia

Location

Central Research Institute for Tuberculosis at Russian Medical Sciences

Moscow, 107564, Russia

Location

Moscow State Medical-Dentist University n.a. A.I. Evdokimov on basis of SMHI "City Hospital № 62", branch 5

Moscow, 121552, Russia

Location

Russian Medical Academy of postgraduate education of Ministry of Healthcare on basis of city's Clinical Hospital № 52

Moscow, 123995, Russia

Location

Ryazan State Medical University

Ryazan, 390005, Russia

Location

State Budgetary Institution of Healthcare "Leningrad region Clinical Hospital"

Saint Petersburg, 194291, Russia

Location

Saint Petersburg State Monetary Healthcare Institution "Nicolaevskiy Hospital"

Saint Petersburg, 19510, Russia

Location

"Medical Researches Institute" LLC

Saint Petersburg, 196084, Russia

Location

State Healthcare Institution "Regional Clinical Hospital"

Saratov, 410053, Russia

Location

Federal State Budgetary Educational Institution of the Higher Education "Smolensk State Medical

Smolensk, 214019, Russia

Location

State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"

Yaroslavl, 150003, Russia

Location

Related Publications (1)

• 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.

  PMID: 33095411 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

histamine glutarimide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single-blinding was conducted during the run-in period of the study (each patient received simultaneously 3 tablets of Placebo matching 2, 10, and 100 mg XC8), the form of the package (a blister with three lines of tablets of each dosage), corresponding package labeling of the study drug (IP kit numbers). Double-blinding in the treatment period was provided by Placebo masking (each patient received simultaneously 3 tablets corresponding to 2 mg or Placebo, 10 mg or Placebo, 100 mg or Placebo), the form of the package (a blister with three lines of tablets of each dosage), corresponding package labeling of the study drug (IP kit numbers) and distribution of the drug by IWRS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: March 1, 2018
• Study Start: September 20, 2016
• Primary Completion: September 27, 2017
• Study Completion: September 27, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)