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Not yet recruitingNCT07294326Updated Dec 19, 2025

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 Phase 4 interventional study of Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment and Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment. in Allergic Rhinitis, sponsored by China-Japan Union Hospital. Not yet recruiting. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by China-Japan Union Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Allergic Rhinitis

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03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 50 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

China-Japan Union Hospital is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are allergic to other 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • DrugIntranasal 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.

  • DrugIntranasal 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment

  2. 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.

    Time frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment

  3. 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.

    Time frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment

  4. 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

    Time frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment

Secondary outcomes

  1. Endoscopic sinus scoring (Lund-Kennedy)

    Time frame: Before the start of treatment, the 14th day of treatment

  2. blood cell count

    Time frame: Before the start of treatment, the 14th day of treatment

  3. serum IgE level

    Time frame: Before the start of treatment, the 14th day of treatment

  4. nasal secretions IgE level

    Time frame: Before the start of treatment, the 14th day of treatment

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07294326
Lead sponsor
China-Japan Union Hospital
Responsible party
Dongdong Zhu (Department Director, China-Japan Union Hospital) — Principal investigator
First posted
Dec 19, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Dec 19, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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