192
Participants
Start Date
June 20, 2018
Primary Completion Date
April 29, 2019
Study Completion Date
December 13, 2019
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.
"Joint Stock Company Outpatient clinic Medical Regional United System of Contracts", Moscow
"Federal State Budgetary Institution Research Institute of Pulmonology of the Federal Medical and Biological Agency", Moscow
"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
"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
"Limited Liability Company MDP-Medical Group", Odintsovo
"State Budgetary Healthcare Institution of the Arkhangelsk Region The First City Clinical Hospital named after E.E. Volosevich", Arkhangelsk
"St. Petersburg State Budgetary Healthcare Institution Vvedenskaya City Clinical Hospital", Saint Petersburg
"Limited Liability Company Medical Technologies LLC Medical Technologies", Saint Petersburg
"St. Petersburg State Budgetary Healthcare Institution City Consultative and Diagnostic Center No. 1", Saint Petersburg
"Limited Liability Company Baltic Medicine LLC Baltic Medicine", Saint Petersburg
"State Budgetary Institution of Health Care of the Leningrad Region Center for Occupational Pathology", Saint Petersburg
"Regional State Budgetary Healthcare Institution Clinical Hospital No. 1", Smolensk
"Municipal budgetary health care institution Krasnodar City Clinical Emergency Hospital", Krasnodar
"Budgetary healthcare institution of the Voronezh region Voronezh Regional Clinical Hospital No. 1", Voronezh
"State Budgetary Healthcare Institution Republican Clinical Hospital named after G.G. Kuvatov", Ufa
"State Budgetary Healthcare Institution of the Vladimir Region Regional Clinical Hospital", Vladimir
"State Budgetary Healthcare Institution of the Perm Territory Clinical Medical and Sanitary Unit No. 1", Perm
"Budgetary Public Health Facility of the Sverdlovsk Region Sverdlovsk Regional Clinical Hospital No. 1", Yekaterinburg
"State Budgetary Institution of Health of the Novosibirsk Region City Clinical Hospital No. 2", Novosibirsk
"State Budgetary Healthcare Institution of the Novosibirsk Region State Novosibirsk Regional Clinical Hospital", Novosibirsk
"Federal State Budgetary Educational Institution of Higher Education Siberian State Medical University of the Ministry of Health of the Russian Federation", Tomsk
"Budgetary health care institution of the Omsk region City Clinical Hospital No. 1 named after AN Kabanov", Omsk
"State Autonomous Healthcare Institution of the Kemerovo Region Kemerovo Regional Clinical Hospital named after S.V. Belyaev", Kemerovo
"Regional State Budgetary Healthcare Institution Regional Clinical Hospital", Barnaul
AO GENERIUM
INDUSTRY