Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua: a Randomized, Double Blind,Placebo Controlled, Phase III Trial

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: AIT drops
* Drug: placebo drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of seasonal rhinitis symptoms for over 2 years artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) of class 3 or higher patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol. patients who are able to understand the information given and the consent and complete the daily record card. Exclusion Criteria: patients with severe asthma, perennial allergic rhinitis, cancer or other serious diseases that are unfit to receive allergen immunotherapy patients who are taking β-antagonists or have taken systemic corticosteroids in last 4 weeks patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: artemisia annua allergen extract drops<br> | Drug: AIT drops<br>* once a day<br>|
| Placebo Comparator: Placebo drops<br> | Drug: placebo drops<br>* once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) |