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

This is an interventional treatment trial for Bronchial Asthma focused on measuring omalizumab, humanized monoclonal antibodies, safety, bronchial asthma, equivalence, biosimilar, anti-allergic agents, anti-asthmatic agents, respiratory system agents, hypersensitivity, immune system diseases, urticaria, immunogenicity Read More

Inclusion Criteria:

1. Men and women of the ages between 18 and 75 at the time of the Informed Consent Form signature.
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 200 ml from the baseline value, which is measured if inhaled short-acting β2-agonists are withdrawn for ≥4 hours or long-acting β2-agonists ≥12 hours, after 10-15 minutes after inhalation 200-400 mcg salbutamol or equivalent.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:

1. The initial concentration of total IgE and body weight do not correspond to the range in the dosing table for omalizumab dose-ranging.
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.