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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment; Drug: Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range: 12-75 years old, both male and female are welcome;
2. The diagnostic criteria for moderate to severe allergic rhinitis refer to the "Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, revised edition)", which states: (1) Symptoms: the presence of 2 or more symptoms such as paroxysmal sneezing, watery nasal discharge, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than 1 hour per day, with symptoms appearing for at least 1 year, a single symptom score (TNSS score standard) of 2 points or more, and a total nasal symptom score (TNSS score standard) of 6 points or more. May be accompanied by eye symptoms, including itching, tearing, redness, and burning sensation. (2) Signs: Pale and edematous nasal mucosa, accompanied by watery nasal secretions (3) Allergen testing: at least one allergen SPT and/or serum specific IgE positive, or nasal provocation test positive. (4) Severe or severe symptoms that have a significant impact on quality of life, including (i) sleep disorders, (ii) disruptions to daily activities, leisure, and/or exercise, (iii) disruptions to learning or work, (iv) anxiety, depression, or restlessness;
3. The enrolled patients reside in Northeast China and meet the follow-up requirements, including Hulunbuir City, Xing'an League, Tongliao City, Chifeng City, and Xilingol League in Heilongjiang Province, Jilin Province, Liaoning Province, and Inner Mongolia Autonomous Region;
4. The subjects voluntarily participated in this study and signed a written informed consent form.

Exclusion Criteria:

1. Patients who are allergic to other excipients such as azelastine hydrochloride, fluticasone propionate, or related drugs;
2. Pregnant women;
3. Patients with arrhythmia, severe organic heart disease, glaucoma, prostate enlargement, active tuberculosis, malignant tumors, systemic immune diseases, or uncontrolled active infections, such as acute upper respiratory tract infections, who cannot be treated with relevant drugs;
4. Other patients who are unwilling to cooperate with treatment or unable to cooperate with follow-up due to serious systemic or mental illnesses;
5. There are certain organic diseases of the nasal cavity, such as benign and malignant tumors of the nasal cavity, chronic sinusitis with nasal polyps, etc;
6. Age<12 years old or>75 years old;
7. Patients who have received allergen specific immunotherapy or biologic therapy within the past 6 months;
8. Those who cannot tolerate serious systemic or local adverse reactions during relevant examinations or specimen collection;
9. Researchers believe that patients who cannot be included in the group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Nasal Symptom Score (TNSS)	Description: The minimum possible scale value is 0, and the maximum possible scale value is 12. The higher scores mean a worse outcome.	Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
Total Ocular Symptom Score (TOSS)	The minimum possible scale value is 0, and the maximum possible scale value is 9. The higher scores mean a worse outcome.	Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	The minimum possible scale value is 0, and the maximum possible scale value is 168. The higher scores mean a worse outcome.	Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
General Health Status Score (SF36)	The general health status score of patients is evaluated in nine dimensions: physiological function (PF), physiological function (RP), physical pain (BP), general health status (GH), energy (VT), social function (SF), emotional function (RE), mental health (MH), and health change (HT). Scores for each dimension range from 0 to 100, with higher scores indicating higher quality of life	Before the start of treatment, on the 3rd, 7th, and 14th day of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Endoscopic sinus scoring (Lund-Kennedy)	Before the start of treatment, the 14th day of treatment
blood cell count	Before the start of treatment, the 14th day of treatment
serum IgE level	Before the start of treatment, the 14th day of treatment
nasal secretions IgE level	Before the start of treatment, the 14th day of treatment

Collaborators and Investigators

• Sponsor: China-Japan Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Agents; Neurotransmitter Agents; Pharmacologic Actions; Chemical Actions and Uses; Histamine Antagonists; Therapeutics
• Other Study ID Numbers: 2025101109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No