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.
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Azelastine + Mometazone, nasal spray; Momat Rhino Advance
Intervention type(s): Combination Product; Combination Product
Intervention description(s): 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
Intervention MeSH terms: Azelastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment