Prospective, multicenter, open, randomized, parallel, clinical study for assessment of comparative efficacy and safety of Azelastine +Mometasone Sandoz (main group) and Momat Rino Advance (control group) administered as a monotherapy to patients with seasonal allergic rhinitis (SAR).
The maximum observation period will be 22 days. Study periods * Screening (Visit 1): 1 day prior to Run-In period start (-4 day before study treatment ). * Run-In Period: 3 days prior to first administration of test product/reference product (-3 to -1 days before study treatment). * Randomization (Visit 2): assignment of test product/reference product to the patient (study treatment: day 1). * Administration of test product/reference product within Study days 1 to 14 and observation at Visits 2, 3, 4 which correspond to study days 1, 7, 15, respectively. * Period of follow-up (Visit 5): 36-96 h after last administration of test product/reference product. Performed in a form of a phone call (study treatment: days 16-18). Patients meeting the inclusion criteria and not meeting the non-inclusion criteria will be randomized into 2 groups in a 1:1 ratio. Dose of test product/reference product and dosing regimen used in this study are based on PIL of original product Momat Rino Advance approved by Ministry of Healthcare of the Russian Federation which is used in this study as a reference product. Test product and reference product in this study will be administered according to the following regimen: Group 1 (n=236) will receive test product Azelastine + Mometasone, nasal spray, 140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days. Group 2 (n=236) will receive reference product Momat Rhino Advance, nasal dosed spray, 140 mcg + 50 mcg mcg/dose (Glenmark Pharmaceuticals Limited., India), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days All study procedures for both groups at each phase of study are identical.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily, morning and evening (recommended interval between administrations is approximately 12 hours), for 14 consecutive days.
140 µg + 50 µg/dose - one actuation into each nostril twice daily - morning and evening (interval between administrations is 12 hrs), corresponding to 560 µg/day of azelastine and 200 µg/day of mometasone for 14 consecutive days
Sandoz Investigative Site
Chelyabinsk, Russia
Sandoz Investigative Site
Khasavyurt, Russia
Sandoz Investigative Site
Krasnodar, Russia
Mean total score change as per scale r-TNSS (AM/PM) with initial total score
r-TNSS (reflective Total Nasal Symptom Score) consists of 4 symptom scores (Nasal congestion, Runny nose, Itchy nose, Sneezing), each of which can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. By its nature, the total index r-TNSS is a rank indicator, it is an integer from the range from 0 to 12 points. As a working indicator, the average between the morning and evening values is used. As a measure of the effect of the drug, the change in the index relative to the initial value is used. Baseline is defined as the average r-TNSS score over three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration).
Time frame: Day 1, 7 and 15 post treatment
Mean total score change as per scale i-TNSS (AM/PM) with initial total score
i-TNSS (instantaneous Total Nasal Symptom Score) - TNSS scale consists of 4 symptom scores for assessment of SAR nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing) that reflects intensity of nasal symptoms immediately at the moment of their assessment and filling of questionnaire. Each score can be scored on a 4-point scale (0-3). Higher scores mean a more severe symptom. Total score as per scale i-TNSS = (Average morning score (AM) as per scale i-TNSS + Average evening score (PM) as per scale i-TNSS) / 2 Initial total score as per scale i-TNSS = Is an average total score as per scale i-TNSS for three days of the Run-in period (2 morning (AM) and 3 evening (PM)) plus morning measurements of study day 1 (assessment in the morning prior to first administration).
Time frame: Day 1, 7 and 15 post treatment
Mean change in total score as per scales i-TNSS and r-TNSS with initial total score
Mean change in total score as per scales i-TNSS and r-TNSS with initial total score was reported.
Time frame: Day 1, 7 and 15 post treatment
Change in Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S))
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Masking
DOUBLE
Enrollment
472
Sandoz Investigative Site
Nal'chik, Russia
Sandoz Investigative Site
Pyatigorsk, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
...and 5 more locations
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. RQLQ is a 7-point scale (0 = not impaired at all - 6 = severely impaired).
Time frame: Day 1, 7 and 15 post treatment
Number of Adverse events
Number of Adverse events were reported.
Time frame: throughout the study, approximately 18 days
Proportion of patients with at least one adverse event
Proportion of patients with at least one adverse event were reported.
Time frame: throughout the study, approximately 18 days
Proportion of patients who discontinued treatment because of an adverse event
Proportion of patients who discontinued treatment because of an adverse event were reported.
Time frame: throughout the study, approximately 18 days