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| Name | Class |
|---|---|
| Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. | INDUSTRY |
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Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), both of which are effective and safe alternatives.
The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week SLIT schedule, where the maintenance dose would be reached within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were administered by means of sublingual drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| artemisia annua (sweet sagewort) allergen extract drops | Active Comparator | Drug: sublingual immunotherapy drops |
|
| Placebo drops | Placebo Comparator | Drug: sublingual placebo drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sublingual immunotherapy drops | Drug | artemisia annua (sweet sagewort) allergen extract drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline symptom scores at Week 16 | Primary outcome is the assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales, ranging from 0(asymptomatic) to 3(most severe). | at baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Assessment data from all patients whom will record on diary cards their quality-of-life measures for rhinitis(rhinoconjunctivitis quality of life questionnaire,RQLQ), including 28 questions, ranging from 0 (do not affect quality of life) to 6 (severely affect quality of life). | at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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experiment:placebo=2:1
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| Placebo drops | Drug | sublingual placebo drops |
|
| Medication scores | Assessment data from all patients whom will record on diary cards their medication usage. | at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment |
| Immunologic Changes-IgE | Changes in total serum IgE, specific IgE levels in peripheral blood. | at baseline, Week 16, Week 32 |
| Immunologic Changes-M2 population | Changes in M2 population in peripheral blood and nasal secretion (Flow cytometry). | at baseline, Week 16, Week 32 |
| Change of symptom scores | Assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales. | at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |