Skip to content

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

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
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112481
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

Control group:For treatment with intranasal corticosteroids (INCS) combined with oral antihistamines (OAH), choose fluticasone propionate nasal spray (Flixonase) combined with mizolastine hydrochlorid
Experimental group:Intranasal corticosteroids (INCS) combined with intranasal antihistamines (INAH) treatment, choose Nasonex fluticasone nasal spray (Dimens), 1 spray per nostril (137 µg mometasone f

Sponsors

China-Japan Union Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 12-75 years, both male and female; 2. The diagnostic criteria for moderate to severe allergic rhinitis refer to the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)" as follows: (1) Symptoms: At least two of the following symptoms: paroxysmal sneezing, clear rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating more than 1 hour per day. Symptoms have been present for at least 1 year since onset, with a score of 2 or more for any single symptom (based on TNSS scoring standards) and a total nasal symptom score of 6 or more (based on TNSS scoring standards). Eye symptoms may also be present, including itchy eyes, tearing, redness, and burning sensation; (2) Signs: Pale, edematous nasal mucosa with watery nasal discharge; (3) Allergen testing: Positive for at least one allergen via skin prick test (SPT) and/or serum-specific IgE, or positive nasal challenge test; (4) Symptoms are moderate to severe, significantly affecting quality of life, including 1) Sleep disorders; 2) Daily activities, leisure, and/or exercise are affected; 3) Learning or work is affected; 4) Anxiety, depression, or restlessness; 3. Participants reside in the northeastern region of China and meet the follow-up requirements (including Heilongjiang Province, Jilin Province, Liaoning Province, and Hohhot, Xingan League, Tongliao, Chifeng, and Xilin Gol League in Inner Mongolia Autonomous Region); 4. Subjects voluntarily participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to excipients in similar medications such as hydrochloride mometasone, fluticasone propionate, or related drugs; 2. Pregnant women; 3. Patients with arrhythmia, severe organic heart disease, glaucoma, benign prostatic hyperplasia, active tuberculosis, malignancy, systemic autoimmune disease, or uncontrolled active infections such as acute upper respiratory tract infection, who cannot use the relevant medications; 4. Patients who are unwilling or unable to cooperate with treatment or follow-up due to severe systemic diseases or mental disorders; 5. Patients with certain nasal structural diseases, such as benign or malignant nasal tumors, or chronic sinusitis with nasal polyps; 6. Patients younger than 12 years old or older than 75 years old; 7. Patients who received allergen-specific immunotherapy or biologic therapy in the past 6 months; 8. Patients who cannot tolerate relevant tests or experience severe systemic or local adverse reactions during specimen collection; 9. Patients deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Total Nasal Symptom Score (TNSS);Total Ocular Symptom Score (TOSS);Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ);General Health Status Score (SF36);

Secondary

MeasureTime frame
Endoscopic sinus scoring (Lund-Kennedy);blood cell count;serum IgE level;nasal secretions IgE level ;

Countries

China

Contacts

Public ContactDongdong Zhu

China-Japan Union Hospital of Jilin University

zhudd@jlu.edu.cn+86 135 7877 2290

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026