Bronchial AsthmaPhase 3NAPNCT04607629
An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma
A Phase 3 study testing Genolar® + Symbicort® and Xolair® + Symbicort® in people with Bronchial Asthma, run by AO GENERIUM at 24 sites in Russia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Genolar® + Symbicort® and Xolair® + Symbicort®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 24 sitesRussia
- Study dates
- 20 Jun 2018to 13 Dec 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 4th 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 200 ml from the baseline value, which is measured if inhaled short-acting β2-agonists are withdrawn for ≥4 hours or long-acting β2-agonists ≥12 hours, after 10-15 minutes after inhalation 200-400 mcg salbutamol or equivalent.
- OR
Show all 9Show fewer
- 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.
Who cannot join
- 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%.
Show all 11Show fewer
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Russia24 sites
State Budgetary Healthcare Institution of the Arkhangelsk Region "The First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, 163001
Regional State Budgetary Healthcare Institution "Regional Clinical Hospital"
Barnaul, 656024
State Autonomous Healthcare Institution of the Kemerovo Region "Kemerovo Regional Clinical Hospital named after S.V. Belyaev"
Kemerovo, 650066
Municipal budgetary health care institution "Krasnodar City Clinical Emergency Hospital"
Krasnodar, 350042
Joint Stock Company "Outpatient clinic" Medical Regional United System of Contracts"
Moscow, 109544
Federal State Budgetary Institution "Research Institute of Pulmonology of the Federal Medical and Biological Agency"
Moscow, 115682
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
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
State Budgetary Institution of Health of the Novosibirsk Region "City Clinical Hospital No. 2
Novosibirsk, 630051
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, 630087
Limited Liability Company "MDP-Medical Group"
Odintsovo, Moscow Oblast, 143005
Budgetary health care institution of the Omsk region "City Clinical Hospital No. 1 named after AN Kabanov"
Omsk, 644112
State Budgetary Healthcare Institution of the Perm Territory "Clinical Medical and Sanitary Unit No. 1
Perm, Perm Territory, 614077
State Budgetary Institution of Health Care of the Leningrad Region "Center for Occupational Pathology"
Saint Petersburg, Sankt-Peterburg, 195271
St. Petersburg State Budgetary Healthcare Institution "Vvedenskaya City Clinical Hospital"
Saint Petersburg, 191180
Limited Liability Company "Medical Technologies" LLC "Medical Technologies"
Saint Petersburg, 192148
St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"
Saint Petersburg, 194354
Limited Liability Company "Baltic Medicine" LLC "Baltic Medicine"
Saint Petersburg, 194356
Regional State Budgetary Healthcare Institution "Clinical Hospital No. 1"
Smolensk, 214006
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
Tomsk, 634050
State Budgetary Healthcare Institution "Republican Clinical Hospital named after G.G. Kuvatov"
Ufa, Bashkortostan Republic, 450005
State Budgetary Healthcare Institution of the Vladimir Region "Regional Clinical Hospital"
Vladimir, 600023
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh, 394066
Budgetary Public Health Facility of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg, 620102
About this study
Official title: A Comparative Study of Efficacy and Safety of Genolar® and Xolar® in Treating Patients With Moderate to Severe Persistent Atopic Bronchial Asthma Inadequately Controlled With Stage 4 GINA (2017) Treatment
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)
Read the detailed description
There is an increasing incidence of bronchial asthma (BA) and other allergic diseases around the world. Bronchial asthma suffers from 4 to 10% of the world population, in Russian Federation, the incidence of BA across the adult population ranges from 2.2 to 5-7%, in the child population is about 10%.
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
- Bronchial Asthma
- Being tested
- Genolar® + Symbicort®, Xolair® + Symbicort®
- 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
- Medical subject headings
- Asthma, Hypersensitivity, Immune System Diseases, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genolar® + Symbicort®Biological
Also called omalizumab & (budesonide+formoterol), GNR-044 & (budesonide+formoterol)
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®Biological
Also called omalizumab & (budesonide+formoterol)
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.
| Study group | Role | What they receive |
|---|---|---|
| Genolar® + Symbicort® | Experimental | omalizumab \& inhalation of budesonide+formoterol Receives: Biological: Genolar® + Symbicort® |
| Xolair® + Symbicort® | Active comparator | omalizumab \& inhalation of budesonide+formoterol Receives: Biological: Xolair® + Symbicort® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
An exacerbation is defined as the patient needs to use oral or intravenous glucocorticosteroids (prednisolone) or to increase the dose of inhaled corticosteroids ≥2 times due to an exacerbation of asthma symptoms and a fall in peak expiratory flow (PEF) or forced expectorant volume for 1 sec (FEV1) resistant to treatment with inhalation drugs
Measured: 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
PEF measures how much air patient can breathe out using the greatest effort. It is used in the monitoring and treatment of asthma to determine treatment efficacy
Measured: 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®)
FEV1 is the amount of air that can be forcefully exhaled in one second. Clinically, the percentage of predicted FEV1 appears to be a valid marker for the degree of airway obstruction with asthma and other respiratory conditions. Together with asthma symptoms and use of inhaled short-acting beta2-agonists, FEV1 is used to classify the severity of asthma and treatment efficacy
Measured: 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
ACQ is a patient-reported tool to assess asthma control in patient ≥ 6 years of age. ACQ was used to evaluate asthma control in patients and treatment efficacy
Measured: 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®)
A day without asthma symptoms
Measured: For 26 weeks of comparative treatment (Genolar® vs. Xolair®)
Neutralizing antibody rate
long-term immunogenicity study of Genolar®
Measured: Baseline, in 6, 26, 52 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start20 Jun 2018
- Primary completion29 Apr 2019
- Study completion13 Dec 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana A Markova, MD, Study chair, Head of the scientific department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607629
- Sponsor's protocol ID
- OMA-BA-III
- Other IDs
- №189. eff.data 25 Apr 2018
- Acronym
- NAP
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NAP
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Efficacy and Safety of Genolar® and Xolar® in Treating Patients With Moderate to Severe Persistent Atopic Bronchial Asthma Inadequately Controlled With Stage 4 GINA (2017) Treatment
- ClinicalTrials.gov ID
- NCT04607629
- Acronym / sponsor ID
- NAP / OMA-BA-III
- Conditions
- Bronchial Asthma
- Keywords
- omalizumab, humanized monoclonal antibodies, safety, bronchial asthma, equivalence, biosimilar, anti-allergic agents, anti-asthmatic agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 29 Oct 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.
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)
Detailed description
There is an increasing incidence of bronchial asthma (BA) and other allergic diseases around the world. Bronchial asthma suffers from 4 to 10% of the world population, in Russian Federation, the incidence of BA across the adult population ranges from 2.2 to 5-7%, in the child population is about 10%.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| Genolar® + Symbicort® | Experimental | Biological: Genolar® + Symbicort®omalizumab \& inhalation of budesonide+formoterol |
| Xolair® + Symbicort® | Active comparator | Biological: Xolair® + Symbicort®omalizumab \& inhalation of budesonide+formoterol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- 4th 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Genolar® + Symbicort®Also: omalizumab & (budesonide+formoterol), GNR-044 & (budesonide+formoterol)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. | Biological | Genolar® + Symbicort® |
| Xolair® + Symbicort®Also: omalizumab & (budesonide+formoterol)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. | Biological | Xolair® + Symbicort® |
Primary outcome
Patients proportion with an investigator rating "excellent" or "good" on the Global Evaluation of Treatment Effectiveness (GETE) scale after 26 weeks of comparative treatment
Time frame: In 26 weeks after comparative treatment beginning (Genolar® vs. Xolair®)
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).
6 secondary outcomes
The number of bronchial asthma exacerbations per patient for 26-week period of comparative treatment
Time frame: 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
Time frame: 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®)
Time frame: 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
Time frame: 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®)
Time frame: For 26 weeks of comparative treatment (Genolar® vs. Xolair®)
Neutralizing antibody rate
Time frame: Baseline, in 6, 26, 52 weeks of treatment
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 29 Oct 2020.
- Clinical Trials RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No. NAP
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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.
Oksana A Markova, MD study chair
Head of the scientific department
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genolar® + Symbicort® and Xolair® + Symbicort® in people with Bronchial Asthma, run by AO GENERIUM at 24 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 9 inclusion and 11 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 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Patients proportion with an investigator rating "excellent" or "good" on the Global Evaluation of Treatment Effectiveness (GETE) scale after 26 weeks of comparative treatment (time frame: In 26 weeks after comparative treatment beginning (Genolar® vs. Xolair®)). 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 29 Oct 2020.