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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal corticosteroids (INCS) combined with oral antihistamines (OAH) used for treatment | Drug | 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. |
| 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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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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|
| 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. |
|
| 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 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
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