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临床试验/NCT02014623
NCT02014623已完成4 期

Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis

Bayside Health1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months

研究概览

简要总结

Allergic diseases represent a major health issue worldwide and epidemiological studies in Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including the sublingual route (SLIT) and recently sublingual tablets for pollen allergy immunotherapy became available. The tablets are safe and easy to use and contain pollen extracts from 5 of the most common allergy-causing European grasses but include ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not fully understood. The investigators propose conducting a longitudinal open label study to investigate the immunological changes that occur with the 5 grass pollen sublingual immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects. The investigators will investigate the induction of relevant T cell regulatory immune mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4. Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to inform decisions for the greater application of this treatment for subjects with moderate and severe allergic rhinitis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects of Chinese heritage or non-Chinese heritage
  • Clinical diagnosis of moderate to severe seasonal allergic rhinitis
  • Ryegrass-specific IgE : CAP-Pharmacia score > 1

排除标准

  • Ongoing immunotherapy or previous immunotherapy (within last 5 years)
  • Continuous oral corticosteroids
  • Moderate, severe or unstable asthma
  • Standard contraindications for allergen immunotherapy
  • Ongoing treatment with β-blockers
  • Immunodeficiency diseases
  • Malignancy
  • Significant inflammatory condition or disease in the oral cavity

研究组 & 干预措施

Grass pollen sublingual immunotherapy tablet

Active Comparator

A sublingual allergen immunotherapy tablet (Oralair) containing: 300 index of reactivity (IR) of 5 grass pollen allergen extracts:perennial ryegrass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum) in an open label fashion administered for 4 months prior to the pollen season.

干预措施: Grass pollen sublingual immunotherapy tablet (Other)

Control

Other

Standard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines

干预措施: Control (Drug)

结局指标

主要结局

Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months

时间窗: Baseline, 4 months, 12 months

次要结局

  • Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months(Baseline, 4 months, 8 months, 12 months)
  • Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months(Baseline,4 months, 12 months)
  • Change in Ryegrass-specific IgE at 4 months and 12 months(Baseline, 4 months, 12 months)
  • Change in Quality of Life assessed by an Allergic Rhinitis Quality of Life Questionnaire at 4, 8 and 12 months(Baseline, 4 months, 8 months, 12 months)
  • Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months(Baseline, 4 months, 8 months, 12 months)

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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