Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Symptoms and medication scores comparison between active and placebo group
研究概览
简要总结
The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local allergic rhinitis with sensitization to grass pollen
- •Skin prick test and serum specific IgE negative to grass pollen.
- •Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen.
- •Written informed consent
排除标准
- •Immunological diseases
- •Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers.
- •Treatment with beta-blockers
- •Severe psychological disorders
- •Severe atopic dermatitis
- •FEV1 < 70% of reference value after treatment
- •Hypersensitivity or intolerance to excipients and / or medication trial.
- •Failure to adequately perform diagnostic tests or treatment.
- •Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response.
- •Immunotherapy in the 5 years prior to their inclusion in the study.
- •Pregnant women or at risk of pregnancy and lactating women.
结局指标
主要结局
Symptoms and medication scores comparison between active and placebo group
时间窗: two years
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
次要结局
- Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage(2 years)
- Heart rate(2 years)
- Blood pressure(2 years)
- Intradermal test (IDT) with phleum(2 years)
- FEV1(2 years)
- Adverse events(2 years)
- Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage.(2 years)
- Quality of life questionnaire RQLQ(2 years)
- Response to nasal allergen provocation test with phleum (NAPT-Phl)(two years)
- Skin prick-test (SPT) with phleum.(2 years)
研究者
Miguel Blanca Gomez
Director Allergy Unit
Plaza del Hospital Civil