NCT05311475

Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis

A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatment of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 669 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The trial will be conducted as a prospective, randomized, multinational, multicenter, double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering from seasonal allergic rhinitis.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Mometasone	Mometasone furoate nasal spray (50 mcg per actuation)
DRUG	Azelastine	Azelastine hydrochloride nasal spray (140 mcg per actuation)
DRUG	Placebo	Placebo nasal spray

Timeline

• Start date: 2022-04-04
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2022-04-05
• Last updated: 2023-07-11

Locations

28 sites across 4 countries: Bulgaria, Germany, Moldova, Poland