Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

Study Overview
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Brief Summary
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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.

Official Title
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Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Seasonal Allergic Rhinitis: a Randomized, Double Blind, Placebo Controlled Trial

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: sublingual immunotherapy drops
* Drug: Placebo drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients aged 18 to 60 years (inclusive). With history of SAR for at least two years, with/without conjunctivitis and asthma Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year. Sensitised to artemisia annua (specific IgE level ≥ 3.5 kilounit per liter). 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 whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level. Patients with oral diseases/ allergies within the run-in period. Patients accepted any kind of operations within 4 weeks of the run-in period. Patients applied for systemic glucocorticoids within 4 weeks in the run-in period. Patients with perennial AR. Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps). Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study. Patients with comorbidity of severe asthma.

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
Interventional Model Description: experiment:placebo=2:1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: artemisia annua (sweet sagewort) allergen extract drops<br>Drug: sublingual immunotherapy drops | Drug: sublingual immunotherapy drops<br>* artemisia annua (sweet sagewort) allergen extract drops<br>|
| Placebo Comparator: Placebo drops<br>Drug: sublingual placebo drops | Drug: Placebo drops<br>* sublingual placebo drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |