Allergic RhinitisPhase 4NCT07294326

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 study testing Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment and Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment. in people with Allergic Rhinitis, run by China-Japan Union Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 to 75 years
Conditions the study is for: Allergic Rhinitis
What is being tested?: Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment and Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment.
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 1 Jan 2026to 1 Nov 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age range: 12-75 years old, both male and female are welcome;
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;
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;
The subjects voluntarily participated in this study and signed a written informed consent form.

Who cannot join

Patients who are allergic to other excipients such as azelastine hydrochloride, fluticasone propionate, or related drugs;
Pregnant women;
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;
Other patients who are unwilling to cooperate with treatment or unable to cooperate with follow-up due to serious systemic or mental illnesses;
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;
Age<12 years old or>75 years old;

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Patients who have received allergen specific immunotherapy or biologic therapy within the past 6 months;
Those who cannot tolerate serious systemic or local adverse reactions during relevant examinations or specimen collection;
Researchers believe that patients who cannot be included in the group.

About this study

Conditions: Allergic Rhinitis
Being tested: Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment, Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment.
Medical subject headings: Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatmentDrug
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.
Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment.Drug
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.

Study groups in NCT07294326
Study group	Role	What they receive
Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment	Active comparator	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. Receives: Drug: Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment
Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment	Experimental	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. Receives: Drug: Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20261 Nov 2026

First posted19 Dec 2025
Study start1 Jan 2026 (estimated)
Primary completion31 Oct 2026 (estimated)
Study completion1 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Allergic RhinitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294326
Sponsor's protocol ID: 2025101109
Status last verified: Nov 2025
First submitted: 7 Dec 2025
Last updated: 19 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children

All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07294326
Acronym / sponsor ID: 2025101109
Conditions: Allergic Rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: China-Japan Union HospitalUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 1 Nov 2026 (estimated)
First posted: 19 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment	Active comparator	Drug: Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatmentIntranasal 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.
Intranasal corticosteroids (INCS) combined with nasal antihistamines (INAH) used for treatment	Experimental	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.

Who may qualify

Ages: 12 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Age range: 12-75 years old, both male and female are welcome;
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;
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;
The subjects voluntarily participated in this study and signed a written informed consent form.

Key exclusion criteria (9 listed)

Patients who are allergic to other excipients such as azelastine hydrochloride, fluticasone propionate, or related drugs;
Pregnant women;
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;
Other patients who are unwilling to cooperate with treatment or unable to cooperate with follow-up due to serious systemic or mental illnesses;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatmentIntranasal 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 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

Primary outcome

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.
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.
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.
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

4 secondary outcomes

Endoscopic sinus scoring (Lund-Kennedy)
Time frame: 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
serum IgE level
Time frame: 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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Individual participant dataSharing planned: Undecided

Related trials for Allergic Rhinitis

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Nasal Symptom Score (TNSS) (time frame: Before the start of treatment, on the 3rd, 7th, and 14th day of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.