EUCTR2014-003204-70-ES进行中（未招募）不适用
Pilot study on asthma control in patients with grass- pollen allergic rhinitis treated with 5 grass-pollen sublingual immunotherapy (Staloral®) vs placebo - 5GRAPS
Dr. Javier Domínguez Ortega0 个研究点开始时间: 2015年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •?Patients of both sexes aged at 12 years of age or over.
- •?Patients with rhinitis or allergic rhino-conjunctivitis who, moreover, suffer asthma due to grass?pollen allergy and present clinical manifestations of asthma during grass-pollen pollination periods (May to July).
- •?Patients who have had persistent rhinitis of moderate or severe intensity during the past year, according to the ARIA classification modified by Valero et al.11
- •?Patients with a clinical diagnosis of allergic respiratory disease, asthma and rhinitis or rhino-conjunctivitis, of at least two years evolution.
- •?Patients with persistent, mild or moderate allergic asthma (GEMA 2009 guide), in which an etiological relation is established with allergy to grass-pollen and clinical manifestations of purely seasonal asthma in grass-pollen pollination periods in Madrid (May to July)
- •?Patients with a CASI index of ? 6 points during the last grass-pollen pollination peak (May-June 2015).
- •?Patients with FEV1 ? 60% during the last grass-pollen pollination peak (May-June 2015).
- •?Sensitization to grass-pollens, detected by prick test (wheal greater than 3 mm diameter on average) using standardized extracts. A prick test of no more than one year old will be accepted as valid at the time of study patient inclusion.
- •?Levels of specific IgE antibodies against main grass-pollen allergens (Phl p 1) ? 17.5 U/ml (class 4 RAST). Laboratory tests of no more than one year old will be accepted as valid at the time of study patient inclusion.
- •?Patients eligible for treatment with allergen immunotherapy who have not received such since February 2011.
- •?Patients who agree to participate in a clinical trial of 3 years duration.
- •?Patients must voluntarily accept to take part in the study, while understanding the procedures and risks that may derive from it and sign a written informed consent form.
- •?Patients must be capable of filling out the self-administered patient?s daily record and questionnaires.
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •?Patients with persistent asthma outside grass-pollen pollination periods.
- •?Patients with intermittent asthma due to another allergen different from grass-pollens while presenting symptoms between the 15th of March and the 15th of August.
- •?Patients with rhinitis and /or rhino-conjunctivitis due to another allergen different from grass-pollens while presenting symptoms between the 15th of March and the 15th of August.
- •?Patients with allergy symptoms of perennial allergens.
- •?Patients who have had asthmatic crises outside the grass-pollen season during the last 3 years (since May 2012)
- •?Patients who smoke or are ex-smokers or do not wish to abstain from smoking during the period that the study lasts (3 years).
- •?Patients with other pulmonary diseases different from asthma.
- •?Patients with FEV1 < 60% at the time of screening.
- •?Patients with severe asthma.
- •?Patients with other nasal diseases different from allergic rhinitis.
- •?Patients with levels of specific IgE antibodies against major allergens of olive (Ole e 1or whole olive extract) of > 3.5 U / ml (class 3 RAST). Laboratory test results of no more than one year old will be accepted (following the same criteria as that for grass-pollens).
- •?Women of a childbearing age who wish to become pregnant during the study period, those who are currently pregnant and/or are breast-feeding, or those who do not wish to use an efficient method of contraception.
- •?Patients who have taken part in another clinical trial during the past month.
- •?Patients taking tricyclic antidepressants, imipramine, central antihypertensives (clonidine or reserpine) or beta-blockers.
- •?Patients who cannot tolerate treatment with Staloral®: hypersensitivity to any of the excipients, serious immune -deficiencies, immune complex diseases, cancer, unstable or badly controlled asthma, autoimmune diseases, diseases that do not tolerate adrenalin usage, serious psychological disorders.
- •?Patients incapable of reading or understanding the quality of life questionnaires used in this study.
- •?Patients who refuse to sign the informed consent form.
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