NCT07294326

A Prospective, Randomized, Controlled Study Comparing the Efficacy of Intranasal Corticosteroids (INCS) Combined With Intranasal Antihistamines (INAH) and INCS Combined With Oral Antihistamines (OAH) in the Treatment of Moderate to Severe Allergic Rhinitis Symptoms

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: China-Japan Union Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Through prospective exploration of the efficacy of intranasal corticosteroids (INCS) combined with intranasal antihistamines (INAH) and INCS combined with oral antihistamines (OAH) in treating moderate to severe allergic rhinitis symptoms, this study aims to provide evidence-based medical evidence for the standardized treatment of patients with moderate to severe allergic rhinitis accompanied by typical nasal and ocular symptoms.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment	Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment. Fluticasone propionate nasal spray (Fushuliang) combined with Azlastine hydrochloride tablets (Kedumin), Fluticasone propionate nasal spray (Fushuliang) 1 spray (50 µ g Fluticasone propionate) on each side of the nostril, twice a day, and Azlastine hydrochloride tablets (Kedumin) 2mg once a day, twice a day, once an hour before breakfast, once at night before sleep, for 14 consecutive days.
DRUG	Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment.	Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment. Azolastine and fluticasone nasal spray (Demins) were selected, and one spray (137 µ g Azolastine Hydrochloride and 50 µ g Fluticasone Propionate) was applied to each nostril twice a day for 14 consecutive days.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-31
• Completion: 2026-11-01
• First posted: 2025-12-19
• Last updated: 2025-12-19