An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma
NCT ID: NCT04607629
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
192 participants
INTERVENTIONAL
2018-06-20
2019-12-13
Brief Summary
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Detailed Description
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Severe BA is associated not only with frequent hospitalizations and increased mortality but also with high treatment costs.
As to it, there is a hot button issue of developing new drugs for treating patients not to be achieved effectively with standard therapy. Considering the leading pathogenesis role of IgE-mediated allergy, the use of drugs to block IgE makes it possible to control the disease at the earliest allergic reaction phase of the development. It was shown that the IgE elimination from the mast cells and basophils surface reduced the severity of acute allergic reactions, reduced the allergen-induced late phase of the immune response and infiltration with inflammatory cells. These anti-IgE antibodies effects have been shown in various studies.
Genolar® (omalizumab) (JSC "GENERIUM", the Russian Federation) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin (IgE) and is a biosimilar of Xolar® ("Novartis Pharma AG", Switzerland).
This III phase study is aimed to compare the effectiveness, safety and immunogenicity of Genolar® (JSC "GENERIUM", Russia) and Xolair® to register of the drug Genolar® (JSC "GENERIUM", the Russian Federation), a lyophilizate for subcutaneous administration, in the Russian Federation.
The study included patients (n = 192) aged 18 to 75 years with moderate to severe persistent atopic bronchial asthma. The diagnosis was documented for ≥1 year. The symptoms of the disease were insufficiently controlled by therapy corresponding to the 4th stage of treatment (GINA, 2017) during ≥2 months before screening. With block randomization, the patients were divided into two groups in a 2: 1 ratio: in group 1 - 127 patients received treatment with Genolar® for 52 weeks ± 3 days, in group 2 - 64 patients received treatment with Xolair® for 26 weeks ± 3 days. The study consisted of a screening period, an induction period for basic treatment standardizing with the using inhaled budesonide + formoterol, a comparative period of treatment with the studied drugs (Genolar® vs. Xolair®) for 26 weeks ± 3 days, and an additional period of continuing treatment with Genolar® for 26 ± 1 week for its long-term immunogenicity study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Genolar® + Symbicort®
omalizumab \& inhalation of budesonide+formoterol
Genolar® + Symbicort®
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.
Xolair® + Symbicort®
omalizumab \& inhalation of budesonide+formoterol
Xolair® + Symbicort®
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.
Interventions
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Genolar® + Symbicort®
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.
Xolair® + Symbicort®
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A documented diagnosis of bronchial asthma for ≥1 year before the Screening;
3. 4th stage of asthma treatment according to GINA (2017) ≥2 months before the Screening;
4. 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;
5. 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.
OR
6. 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%;
7. 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);
8. Atopy for common environmental allergens confirmed at the Screening, or documented atopy for common environmental allergens in history.
Exclusion Criteria
2. Asthma resistant to glucocorticosteroids (inhaled, oral or parenteral).
3. Current smokers, smoker's index (pack / years) \>10. Smoker's index (pack / years) = number of cigarettes smoked per day × smoking experience (years) / 20.
4. Asthma exacerbation during the 4 weeks before randomization.
5. 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.
6. Skipped the basic inhalations with Symbicort® Turbuhaler® during the introductory period of the trial more than 20%.
7. Patients with severe medical conditions that in the view of the investigator prohibits participation in the study.
8. Pregnant or nursing (lactating) women.
9. Monoclonal antibodies administration within 1 year before taking omalizumab.
10. Hypersensitivity to any of the used study drug, to their components, history of an undesirable drug reaction.
11. A history of autoimmune disease.
18 Years
75 Years
ALL
No
Sponsors
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AO GENERIUM
INDUSTRY
Responsible Party
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Principal Investigators
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Oksana A Markova, MD
Role: STUDY_CHAIR
Head of the scientific department
Locations
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State Budgetary Healthcare Institution "Republican Clinical Hospital named after G.G. Kuvatov"
Ufa, Bashkortostan Republic, Russia
Limited Liability Company "MDP-Medical Group"
Odintsovo, Moscow Oblast, Russia
State Budgetary Healthcare Institution of the Perm Territory "Clinical Medical and Sanitary Unit No. 1
Perm, Perm Territory, Russia
State Budgetary Institution of Health Care of the Leningrad Region "Center for Occupational Pathology"
Saint Petersburg, Sankt-Peterburg, Russia
State Budgetary Healthcare Institution of the Arkhangelsk Region "The First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, , Russia
Regional State Budgetary Healthcare Institution "Regional Clinical Hospital"
Barnaul, , Russia
State Autonomous Healthcare Institution of the Kemerovo Region "Kemerovo Regional Clinical Hospital named after S.V. Belyaev"
Kemerovo, , Russia
Municipal budgetary health care institution "Krasnodar City Clinical Emergency Hospital"
Krasnodar, , Russia
Joint Stock Company "Outpatient clinic" Medical Regional United System of Contracts"
Moscow, , Russia
Federal State Budgetary Institution "Research Institute of Pulmonology of the Federal Medical and Biological Agency"
Moscow, , Russia
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, , Russia
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, , Russia
State Budgetary Institution of Health of the Novosibirsk Region "City Clinical Hospital No. 2
Novosibirsk, , Russia
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, , Russia
Budgetary health care institution of the Omsk region "City Clinical Hospital No. 1 named after AN Kabanov"
Omsk, , Russia
St. Petersburg State Budgetary Healthcare Institution "Vvedenskaya City Clinical Hospital"
Saint Petersburg, , Russia
Limited Liability Company "Medical Technologies" LLC "Medical Technologies"
Saint Petersburg, , Russia
St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"
Saint Petersburg, , Russia
Limited Liability Company "Baltic Medicine" LLC "Baltic Medicine"
Saint Petersburg, , Russia
Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
Smolensk, , Russia
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
Tomsk, , Russia
State Budgetary Healthcare Institution of the Vladimir Region "Regional Clinical Hospital"
Vladimir, , Russia
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh, , Russia
Budgetary Public Health Facility of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg, , Russia
Countries
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Related Links
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Clinical Trials Register
Other Identifiers
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№189. eff.data 25 Apr 2018
Identifier Type: OTHER
Identifier Source: secondary_id
OMA-BA-III
Identifier Type: -
Identifier Source: org_study_id