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

Inclusion criteria

• ✓. 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 200 ml from the baseline value, which is measured if inhaled short-acting β2-agonists are withdrawn for ≥4 hours or long-acting β2-agonists ≥12 hours, after 10-15 minutes after inhalation 200-400 mcg salbutamol or equivalent.
• ✓. 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.

Exclusion criteria