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

December 7, 2025 updated by: Dongdong Zhu, China-Japan Union Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Nasal Symptom Score (TNSS)
Time Frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
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)
Time Frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
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)
Time Frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
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)
Time Frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Endoscopic sinus scoring (Lund-Kennedy)
Time Frame: Before the start of treatment, the 14th day of treatment
Before the start of treatment, the 14th day of treatment
blood cell count
Time Frame: Before the start of treatment, the 14th day of treatment
Before the start of treatment, the 14th day of treatment
serum IgE level
Time Frame: Before the start of treatment, the 14th day of treatment
Before the start of treatment, the 14th day of treatment
nasal secretions IgE level
Time Frame: Before the start of treatment, the 14th day of treatment
Before the start of treatment, the 14th day of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China-Japan Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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