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Prospective, Multicenter, Open-label, Randomized, Parallel, Clinical Study for Assessment of Comparative Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Sandoz Investigative Site
Chelyabinsk, Russia
Sandoz Investigative Site
Khasavyurt, Russia
Sandoz Investigative Site
Krasnodar, Russia
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
Start Date
February 13, 2023
Primary Completion Date
June 14, 2023
Completion Date
June 14, 2023
Last Updated
August 4, 2023
472
ACTUAL participants
Azelastine + Mometazone, nasal spray
COMBINATION_PRODUCT
Momat Rhino Advance
COMBINATION_PRODUCT
Lead Sponsor
Sandoz
NCT06837233
NCT03570957
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05540717