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

Background. To study efficacy and safety of Dezrinit (mometasone furoate, metered dose nasal spray, 200 pg/day) in comparison with Nasonex® (mometasone furoate, metered dose nasal spray, 200 pg/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.

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