An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma

NCT04607629 | Completed Phase 3

• 2 other identifiers: OMA-BA-III№189. eff.data 25 Apr 2018
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 24

Brief Summary

This is a randomized, double-blind, comparative, parallel-group study of the efficacy and safety of Genolar® and Xolair® in the treatment of persistent atopic bronchial asthma of moderate and severe course, whose symptoms are insufficiently controlled by the 4-step treatment GINA (2017)

Conditions

Bronchial Asthma

Keywords

omalizumab; humanized monoclonal antibodies; safety; bronchial asthma; equivalence; biosimilar; anti-allergic agents; anti-asthmatic agents; respiratory system agents; hypersensitivity; immune system diseases; urticaria; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Patients proportion with an investigator rating "excellent" or "good" on the Global Evaluation of Treatment Effectiveness (GETE) scale after 26 weeks of comparative treatment

  Global evaluation of treatment effectiveness (GETE) is a validated tool and has been used to evaluate the clinical response to omalizumab in patients with moderate to severe allergic asthma (IgE-mediated).

  In 26 weeks after comparative treatment beginning (Genolar® vs. Xolair®)

Secondary Outcomes (6)

• The number of bronchial asthma exacerbations per patient for 26-week period of comparative treatment

  For 26 weeks after comparative treatment start (Genolar® vs. Xolair®)

• Mean PEF change in every 4 weeks compared to PEF baseline in patients treated with Genolar® and Xolar® for 26 weeks of comparative treatment

  Every 4 weeks for 26 weeks of comparative treatment (Genolar® vs. Xolair®)

• FEV1 changes from FEV1 baseline at each visit over 26 weeks of comparative treatment (Genolar® vs. Xolair®)

  At the screening, for the Introductory trial period during which the basic therapeutic drug Symbicort Turbuhaler was admitted, before the comparative treatment beginning, in 8, 16, 26 weeks of comparative treatment (Genolar® vs. Xolair®)

• Patients proportion with an ACQ-5 Asthma Control Questionnaire score ≤0.75 after 26 weeks of treatment

  At the screening, before the comparative treatment start, upon 26 weeks of comparative treatment (Genolar® vs. Xolair®) completion

• Number of days without asthma symptoms during the 26-week period of comparison treatment (Genolar® vs. Xolair®)

  For 26 weeks of comparative treatment (Genolar® vs. Xolair®)

Study Arms (2)

Genolar® + Symbicort®

EXPERIMENTAL

omalizumab \& inhalation of budesonide+formoterol

Biological: Genolar® + Symbicort®

Xolair® + Symbicort®

ACTIVE COMPARATOR

omalizumab \& inhalation of budesonide+formoterol

Biological: Xolair® + Symbicort®

Interventions

Genolar® + Symbicort® BIOLOGICAL

The experimental drug dose and administration frequency were determined based on baseline IgE concentration (IU / ml) measured before treatment and current body weight (kg). Depending on the initial IgE concentration and body weight the recommended drug dose was from 75 to 600 mg once in 2 or 4 weeks. The experimental drug Genolar® and the reference drug Xolair® were administered subcutaneously for 26 weeks. Budesonide + formoterol inhalation (dosed powder for inhalation, each delivered dose contains 320 μg budesonide and formoterol fumarate dihydrate 9 μg)) 1 inhalation 2 times a day.

Also known as: omalizumab & (budesonide+formoterol), GNR-044 & (budesonide+formoterol)

Genolar® + Symbicort®

Xolair® + Symbicort® BIOLOGICAL

The experimental drug dose and administration frequency were determined based on baseline IgE concentration (IU / ml) measured before treatment and current body weight (kg). Depending on the initial IgE concentration and body weight the recommended drug dose was from 75 to 600 mg once in 2 or 4 weeks. The experimental drug Genolar® and the reference drug Xolair® were administered subcutaneously for 26 weeks. Budesonide + formoterol inhalation (dosed powder for inhalation, each delivered dose contains 320 μg budesonide and formoterol fumarate dihydrate 9 μg)) 1 inhalation 2 times a day.

Also known as: omalizumab & (budesonide+formoterol)

Xolair® + Symbicort®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of the ages between 18 and 75 at the time of the Informed Consent Form signature.
• A documented diagnosis of bronchial asthma for ≥1 year before the Screening;
• th stage of asthma treatment according to GINA (2017) ≥2 months before the Screening;
• The FEV1 value measured ≥4 hours after the last inhalation of short-acting β2-agonists or ≥12 hours after the last inhalation of long-acting β2-agonists is in the range of ≥40% and ≤80% of the proper value;
• A positive test result for the obstruction reversibility, which is defined as an increase in FEV1 \> 12% and \> 200 ml from the baseline value, which is measured if inhaled short-acting β2-agonists are withdrawn for ≥4 hours or long-acting β2-agonists ≥12 hours, after 10-15 minutes after inhalation 200-400 mcg salbutamol or equivalent.
• Daily PEF variability for 2 weeks before randomization is \>10%, which is defined as the PEF amplitude between the maximum and minimum values during the day, expressed as an average daily PEF percentage and averaged over 2 weeks: (\[maximum per day value - minimum per day value\] / average of the maximum and minimum values per day), averaged over 2 weeks and multiplied by 100%;
• Insufficiently controlled asthma at the Screening despite the correct inhaler use and good adherence to the 4th stage of bronchial asthma treatment (GINA 2017); and the lack of asthma control reasons are not in concomitant diseases, for example, allergic rhinitis. Insufficiently controlled asthma is defined as ≥1.5 points on the ACQ-5 asthma control questionnaire (Asthma Control Questionnaire);
• Atopy for common environmental allergens confirmed at the Screening, or documented atopy for common environmental allergens in history.

You may not qualify if:

• The initial concentration of total IgE and body weight do not correspond to the range in the dosing table for omalizumab dose-ranging.
• Asthma resistant to glucocorticosteroids (inhaled, oral or parenteral).
• Current smokers, smoker's index (pack / years) \>10. Smoker's index (pack / years) = number of cigarettes smoked per day × smoking experience (years) / 20.
• Asthma exacerbation during the 4 weeks before randomization.
• Asthma treatment regimen changes during the Introductory trial period during which the basic therapeutic drug Symbicort Turbuhaler was admitted, until the first injection of study drugs.
• Skipped the basic inhalations with Symbicort® Turbuhaler® during the introductory period of the trial more than 20%.
• Patients with severe medical conditions that in the view of the investigator prohibits participation in the study.
• Pregnant or nursing (lactating) women.
• Monoclonal antibodies administration within 1 year before taking omalizumab.
• Hypersensitivity to any of the used study drug, to their components, history of an undesirable drug reaction.
• A history of autoimmune disease.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (24)

State Budgetary Healthcare Institution "Republican Clinical Hospital named after G.G. Kuvatov"

Ufa, Bashkortostan Republic, 450005, Russia

Location

Limited Liability Company "MDP-Medical Group"

Odintsovo, Moscow Oblast, 143005, Russia

Location

State Budgetary Healthcare Institution of the Perm Territory "Clinical Medical and Sanitary Unit No. 1

Perm, Perm Territory, 614077, Russia

Location

State Budgetary Institution of Health Care of the Leningrad Region "Center for Occupational Pathology"

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

State Budgetary Healthcare Institution of the Arkhangelsk Region "The First City Clinical Hospital named after E.E. Volosevich"

Arkhangelsk, 163001, Russia

Location

Regional State Budgetary Healthcare Institution "Regional Clinical Hospital"

Barnaul, 656024, Russia

Location

State Autonomous Healthcare Institution of the Kemerovo Region "Kemerovo Regional Clinical Hospital named after S.V. Belyaev"

Kemerovo, 650066, Russia

Location

Municipal budgetary health care institution "Krasnodar City Clinical Emergency Hospital"

Krasnodar, 350042, Russia

Location

Joint Stock Company "Outpatient clinic" Medical Regional United System of Contracts"

Moscow, 109544, Russia

Location

Federal State Budgetary Institution "Research Institute of Pulmonology of the Federal Medical and Biological Agency"

Moscow, 115682, Russia

Location

State Budgetary Institution of Health of the City of Moscow "City Polyclinic No. 52 of the Department of Healthcare of the City of Moscow"

Moscow, 117546, Russia

Location

Federal State Budgetary Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education" of the Ministry of Health of the Russian Federation

Moscow, 123995, Russia

Location

State Budgetary Institution of Health of the Novosibirsk Region "City Clinical Hospital No. 2

Novosibirsk, 630051, Russia

Location

State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

Novosibirsk, 630087, Russia

Location

Budgetary health care institution of the Omsk region "City Clinical Hospital No. 1 named after AN Kabanov"

Omsk, 644112, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "Vvedenskaya City Clinical Hospital"

Saint Petersburg, 191180, Russia

Location

Limited Liability Company "Medical Technologies" LLC "Medical Technologies"

Saint Petersburg, 192148, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"

Saint Petersburg, 194354, Russia

Location

Limited Liability Company "Baltic Medicine" LLC "Baltic Medicine"

Saint Petersburg, 194356, Russia

Location

Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"

Smolensk, 214006, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

Tomsk, 634050, Russia

Location

State Budgetary Healthcare Institution of the Vladimir Region "Regional Clinical Hospital"

Vladimir, 600023, Russia

Location

Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"

Voronezh, 394066, Russia

Location

Budgetary Public Health Facility of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, 620102, Russia

Location

Related Links

• Clinical Trials Register

MeSH Terms

Conditions

Asthma; Hypersensitivity; Immune System Diseases; Urticaria

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Oksana A Markova, MD

  Head of the scientific department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Throughout the study, until the end of the comparative treatment study period, neither the investigators nor the patients knew which drug was being administered
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 29, 2020
• Study Start: June 20, 2018
• Primary Completion: April 29, 2019
• Study Completion: December 13, 2019
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (24)