EUCTR2021-002881-42-DE进行中（未招募）1 期
Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from grass pollen allergy - SULGEN grass phase II study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients who signed and dated the patients' informed consent form obtained prior to any study-specific examination.
- •Female or male patients between 18 and 65 years of age, at the time of signing the informed consent form
- •Patients with moderate-to-severe allergic rhinitis / rhino-conjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.
- •Patients with or without well-controlled mild-to-moderate asthma according to GINA guidelines (Global Initiative for Asthma, 2022).
- •Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
- •Sensitization to Phleum pratense, verified by:
- •a)positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and,
- •b)serum allergen-specific IgE to Phleum pratense = 0.7 kU/L (CAP EAST class = 2) and,
- •c) positive response to nasal provocation with Phleum pratense allergen extract (at least at the fourth concentration step)
- •Assumed compliance and ability of the patient to understand the patient´s electronic diary and to follow the instructions of the study staff
- •Safety laboratory results within the normal range or considered to be not clinically significant in any other case
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Previous immunotherapy with grass pollen allergen extract according to the homologous
- •group of grass pollen of the Poaceae group”, as defined in Annex 1 in the Guideline on
- •allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within
- •the last 5 years
- •Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen ,
- •which interfere with the conduct of the study (e. g. with the tNPT), especially if the result
- •in SPT for this allergen is higher than that for Phleum pratense
- •Patients with co-sensitizations to any pollen or mould with overlapping seasons but
- •which are not cross-reactive with Phleum pratense and with specific IgE levels = class
- •2 CAP/PHADIA (unless the relevance can be excluded by component resolved
- •Simultaneous participation in other clinical trials
- •Simultaneous specific immunotherapy with other allergens
- •Participation in a clinical trial in the last three months before enrolment
- •Asthmatic patients with forced expiratory volume (FEV1) = 70 % of predicted normal
- •Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative
- •for Asthma, 2022)
- •Severe acute or chronic inflammatory or infectious diseases
- •Diseases of the immune system such as autoimmune and immune deficiencies (with
- •exception to well controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
- •Chronic or acute diseases of the heart, kidney or liver with severe impairment of their
- •Hypersensitivity to excipients of the IMP
- •Any severe or unstable lung disease (e. g. active tuberculosis, cystic fibrosis, COPD)
- •Chronic or severe acute diseases of nose or eyes
- •Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
- •Therapy with immunoglobulins
- •Completed or ongoing treatment with anti-IgE-antibody
- •Malignancy within the previous 5 years
- •Alcohol, drug, or medication abuse within the past year and/or during the study
- •Use of non-allowed medication (see section 5.3.1)
- •Contraindications for SLIT (Pitsios et al., 2015)
- •Contraindications for SPT
- •Contraindication for NPT
- •Relationship or dependence with the sponsor and/or investigator
- •Legal incapacity
- •Patients who are jurisdictional or governmentally institutionalized
- •Serious systemic reactions to allergen-specific immunotherapy in the past
- •Active chronic urticaria
- •Active severe atopic eczema
- •Existing or intended pregnancy, lactation or inadequate contraceptive measures for
- •woman with child-bearing potential or a positive pregnancy test at screening
- •Severe psychiatric, psychological, or neurological disorders; completed or ongoing longterm
- •treatment with tranquilizers or psychoactive drugs (including tricyclic
- •antidepressants)
- •Risk of non-compliance by the patient with study procedures
研究者
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