EUCTR2007-001454-77-CZ进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adult patients suffering from house dust mite allergic rhinitis
Stallergenes S.A0 个研究点目标入组 486 人开始时间: 2007年6月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 486
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
- •Diagnosis and Criteria for Inclusion:
- •1.Male or female outpatients aged 18 to 50 years (inclusive).
- •2.Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
- •3.Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
- •4.Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
- •5.Negative urine pregnancy test on female patients of childbearing potential.
- •6.House dust mite-related allergic rhinitis for at least 1 year.
- •7.Sensitised to D. pteronyssinus or D. farinae (positive SPT with wheal diameter greater than 3 mm and a specific IgE level = 0.7 kU/L).
- •8.Baseline ARTSS =5 (after completion of the 7-day daily record card).
- •9.Patients who are willing to comply with the protocol.
- •10.Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •1.Whatever the considered allergens, co-sensitisation leading to clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites).
- •2.Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).
- •3.Patients sensitised to cat or dog allergens and living with these animals at home.
- •4.Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- •5.Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 1).
- •6.Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit 1.
- •7.Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit 2.
- •8.FEV1 < 80% of predicted value at Visit 1.
- •9.Patients who received allergy specific immunotherapy for house dust mites in the last 10 years.
- •10.Patients at risk of non-compliance.
- •11.Participation in any clinical study within the 12 weeks before Visit 1.
- •12.Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
- •13.Any change in environmental measures for allergen avoidance during the study.
- •14.Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
- •15.Patients treated with beta-blockers or under continuous corticotherapy.
- •16.Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies.
- •17.Ongoing treatment by immunotherapy with another allergen.
- •18.Patients with a history of drug or alcohol abuse.
研究者
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