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| Name | Class |
|---|---|
| Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. | INDUSTRY |
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Allergic rhinitis (AR) is a common disease of nasal mucosa, affecting 10% to 40% of the population globally. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.Traditionally, AIT is divided into subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October.
The trial is a randomized, double-blind, placebo-controlled, multicentred, phase III trial. 702 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| artemisia annua allergen extract drops | Experimental |
| |
| Placebo drops | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIT drops | Drug | once a day |
| |
| placebo drops |
| Measure | Description | Time Frame |
|---|---|---|
| daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) | the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score | at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day) |
| Measure | Description | Time Frame |
|---|---|---|
| daily total nasal symptom score (dTNSS) | dTNSS was the sum of four nasal symptom scores for nasal congestion, discharge, itching and sneezing (ranging from 0 to 12). Nasal symptoms during the pollen season were rated on a 4-point scale, while 0 = no symptoms, 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital | Beijing | China | ||||
| Beijing Tongren Hospital |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Drug |
once a day |
|
| at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day) |
| daily Rescue Medication Scores (dRMS) | dRMS is the rescue medication score in each day during the peak pollen season (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines. | at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day) |
| Adverse events | the occurrence and severity of adverse events (AEs) and the casual relationship between AEs and the experimental drug | From the first day of SLIT to Visit 9(week 32) |
| Beijing |
| China |
| Peking University People's Hospital | Beijing | China |
| West China Hospital, Sichuan University | Chendu | China |
| Qingdao Municipal Hospital | Qingdao | China |
| No. 202 Hospital of PLA (General Hospital of Northern Theater Command ) | Shenyang | China |
| First Hospital of Shanxi Medical University | Taiyuan | China |
| Second Hospital of Shanxi Medical University | Taiyuan | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | China |
| Shaanxi Provincial People's Hospital | Xi'an | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| General Hospital of Ningxia Medical University | Yinchuan | China |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |