Ilina N.I., Fedoskova T.G., Astafieva N.G., Gorychkina L.A., Edin A.S., Lopatin A.S., Ukhanova O.P., Khanova F.M., Khanferyan R.A. Therapeutic comparability of Dezrinit and Nazonex® in control of symptoms of allergic rhinitis. The results of a multicenter, open, randomized, comparative study in parallel groups

· RAJ №3-2016

Ilina N.I.1, Fedoskova T.G.1, Astafieva N.G.2, Gorychkina L.A.3, Edin A.S.4, Lopatin A.S.5,
Ukhanova O.P.6, Khanova F.M.7, Khanferyan R.A.8

1 Institute of Immunology, Moscow, Russia
2 Saratov Medical University named after V.I. Rasumovsky, Russia
3 Russian Medical Academy of Postgraduate Education, Moscow, Russia
4 Limited Liability Company «Alliance Biomedical – Russian group», St. Petersburg, Russia
5 FSBI «Polyclinic No. 1» Business Administration of the President of Russian Federation, Moscow, Russia
6 Stavropol Regional Clinical Center for Specialized types of medical care, Russia
7 «Scientific – Clinical Center of Otorhinolaryngology of the Federal Medical-Biological Agency of
Russia», Moscow
8 Kuban State Medical University, Krasnodar, Russia

Key words: seasonal allergic rhinitis, intranasal glucocorticosteroids, mometasone furoate, randomized
controlled clinical trial, symptoms, efficacy, safety, Dezrinit, Nasonex®

Background. To study efficacy and safety of Dezrinit (mometasone furoate, metered dose nasal spray, 200 μg/day) in
comparison with Nasonex® (mometasone furoate, metered dose nasal spray, 200 μg/day) upon administration for 14
days in adult patients with seasonal allergic rhinitis.
Materials and methods. A total of 141 patients were enrolled into the study at 8 study centers in the RF, of which 134
patients were randomized: 67 patients into the experimental group (Dezrinit) and 67 patients into the comparison group
(Nasonex®). Patients were randomized to receive treatment either with Dezrinit or Nasonex®. Efficacy was assessed based
on reflective Total Nasal Symptom Score (rTNSS) and instantaneous Total Nasal Symptom Score (iTNSS); reflective
Total Ocular Symptom Score (rTOSS) and instantaneous Total Ocular Symptom Score (iTOSS). Overall proportion of
patients who responded to treatment was evaluated according to overall assessment of treatment efficacy both by a
patient and by an investigator. AEs were reported for safety assessment.
Results. After 14 days of treatment a marked improvement of symptoms was observed in both groups based on all
assessed scores. Mean change (SD) in rTNSS from baseline was –11,91 (4,625) scores and –11,64 (4,58) scores in the
experimental and comparison groups, respectively (within group differences, p<0,001). Mean difference (SD) in rTNSS
from baseline between experimental and comparison groups was –0,2 (0,519) scores [95% confidence interval (CI)
–1,231; 0,825]. Analysis of primary efficacy endpoint demonstrated similar results in PP population. Mean change (SD)
in iTNSS, rTOSS and iTOSS from baseline was –5,97 (2,569) and –5,93 (2,809) scores; –6,41 (4,801) and –5,09 (4,505)
scores; –3,38 (2,4) and –2,54 (2,47) scores in the experimental and comparison groups, respectively (within group
differences for all comparisons, p<0,001). Treatment efficacy as assessed by patients and investigators, was evaluated
as complete response and significant relief in both treatment groups: 75 and 73,2% investigators in the experimental
and comparison groups; 75 and 76,2% patients in the experimental and comparison groups, respectively. No serious
adverse events were reported.
Conclusion. Available data confirm efficacy comparability and safety of Dezrinit, when compared to Nasonex®, which
suggests a possibility of safe replacement of the original drug by the generic product without loss of treatment efficacy.