Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: sublingual immunotherapy dropsDrug: Placebo drops
- Registration Number
- NCT03649139
- Lead Sponsor
- Beijing Tongren Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description artemisia annua (sweet sagewort) allergen extract drops sublingual immunotherapy drops Drug: sublingual immunotherapy drops Placebo drops Placebo drops Drug: sublingual placebo drops
- Primary Outcome Measures
Name Time Method change from baseline symptom scores at Week 16 at baseline, 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).
- Secondary Outcome Measures
Name Time Method Quality of life at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment 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).
Medication scores at the pollen season of 2016, baseline, Week 16, Week 32, 6 months after discontinuation of treatment Assessment data from all patients whom will record on diary cards their medication usage.
Immunologic Changes-IgE at baseline, Week 16, Week 32 Changes in total serum IgE, specific IgE levels in peripheral blood.
Immunologic Changes-M2 population at baseline, Week 16, Week 32 Changes in M2 population in peripheral blood and nasal secretion (Flow cytometry).
Change of symptom scores at the pollen season of 2016, Week 16 and 6 months after discontinuation of treatment Assessment data from all patients whom will record on diary cards their symptom scores based on visual analog scales.
Trial Locations
- Locations (1)
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China