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.

PHASE3CompletedINTERVENTIONAL
Enrollment

472

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

June 14, 2023

Study Completion Date

June 14, 2023

Conditions
Seasonal Allergic Rhinitis
Interventions
COMBINATION_PRODUCT

Azelastine + Mometazone, 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.

COMBINATION_PRODUCT

Momat Rhino Advance

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

Trial Locations (15)

150040

Sandoz Investigative Site, Yaroslavl

194156

Sandoz Investigative Site, Saint Petersburg

194354

Sandoz Investigative Site, Saint Petersburg

196158

Sandoz Investigative Site, Saint Petersburg

197342

Sandoz Investigative Site, Saint Petersburg

197706

Sandoz Investigative Site, Saint Petersburg

350012

Sandoz Investigative Site, Krasnodar

355000

Sandoz Investigative Site, Stavropol

357501

Sandoz Investigative Site, Pyatigorsk

360002

Sandoz Investigative Site, Nal'chik

362027

Sandoz Investigative Site, Vladikavkaz

368006

Sandoz Investigative Site, Khasavyurt

400005

Sandoz Investigative Site, Volgograd

410054

Sandoz Investigative Site, Saratov

454048

Sandoz Investigative Site, Chelyabinsk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY

NCT05590598 - 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. | Biotech Hunter | Biotech Hunter