EUCTR2014-005471-88-ES进行中（未招募）不适用
Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against grass pollen allergy
INMUNOTEK, S.L.0 个研究点目标入组 180 人开始时间: 2015年9月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Written informed consent
- •- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to grass pollen allergy
- •- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter)
- •Specific IgE (CAP >3) to grass pollen
- •- Age between 14 and 65 years
- •- Both genders
- •- Subjects capable of giving informed consent
- •- Subjects capable of complying with the dosing regimen
- •- Subjects that have not received immunotherapy in the last 5 years
- •- Subjects presenting sensitization to another aeroallergens and or mites, cats or dogs, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Subjects outside of the age range.
- •- Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to grass pollen and other allergens in the last 5 years.
- •- Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
- •- Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- •-Subjects with persistent severe or not controlled asthma , with a FEV< 70 respect to the reference value in spite of the appropiate pharmacological treatment at the time of the inclusion in the trial.
- •-Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
- •- Subjects that have previously submitted a serious secondary reaction during the skin prick test
- •-Subjects in treatment with beta blockers.
- •- Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
- •- Subject with chronic urticaria in the last 2 years or hereditary angioedema.
- •-Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
- •-Subjects with any other disease not associated with the rinitis/rinoconjuntivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multioperados, kidney diseases,...).
- •- Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
- •- Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
- •-Subject with known allergy to other components of the vaccine different from pollen of grasses.
- •- Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
- •- Direct investigator's relatives.
- •- Pregnant or women at risk of pregnancy and breastfeeding women.
研究者
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