EUCTR2018-004472-35-IT进行中（未招募）1 期
A single arm, open label, dose-escalation study of carbamylated monomeric grass pollen drops in patients with a history of allergic rhinoconjunctivitis
ofarma S.p.A.0 个研究点目标入组 30 人开始时间: 2018年12月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Signed and dated Informed Consent Form by a legally competent patient
- •Female or male patients aged 18–64 years
- •Being in good physical and mental health
- •Confirmed normal renal and liver function (including non-clinically significant deviations as defined per laboratory ranges)
- •For females: non-pregnant, non-lactating with adequate contraception or unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
- •Having the diagnosis of allergy based on all the following criteria:
- •oA medical history of moderate to severe allergic rhinoconjunctivitis for grass pollen allergens for at least 2 years (definition of allergy severity according to ARIA (Bousquet et al., 2001))
- •oA positive skin prick test (SPT, wheal diameter =3 mm) to grass pollen allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal <2 mm
- •oSpecific IgE against grass pollen allergens =0.7 kU/L
- •For asthmatic patients: confirmed diagnosis of controlled, intermittent asthma according to Global Initiative for Asthma (GINA) guidelines with the following treatment (step 1): asthma symptoms are rare, there is no night waking due to asthma, no exacerbations in the last year and normal FEV1, use of short acting beta2-agonists as reliever medication as-needed, without the use of controller medication). If pulmonary function is tested by Peak Expiratory Flow, the patient has to achieve a PEF value =80% of the patient’s reference value.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
- •Previous immunotherapy with grass pollen allergens within the last 5 years
- •Ongoing immunotherapy with grass pollen allergens or any other allergens
- •Being in any relationship with or dependence on the Sponsor, CRO and/or Investigator
- •Inability to understand instructions/study documents
- •History of severe systemic reactions and/or anaphylaxis to food (e.g. peanut, seafood), Hymenoptera venom (e.g. bee, wasp stings), medication (e.g. penicillin), etc.
- •History of hypersensitivity to the excipients of the investigational product
- •Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
- •Chronic asthma or emphysema, i.e. FEV1 <80% of the patient’s reference value or PEF <80% of the patients´ individual optimal value
- •Respiratory tract infection or exacerbation of asthma within 4 weeks before the screening
- •Patients symptomatic to any seasonal inhaled allergens circulating during the study period (e.g. birch, hazel, parietaria) confirmed by medical history and SPT
- •Patients symptomatic to any perennial inhaled allergens (e.g. cat, dog, mites), to which the patients are regularly exposed during the study period, confirmed by medical history and SPT
- •Infections in the oral cavity with severe symptoms
- •Oral inflammation or wounds
- •History of significant renal disease or chronic hepatic disease
- •Malignant active disease (ongoing or within the five past years)
- •Severe autoimmune disease
- •Immune defects including immunosuppression, immunopathies
- •Vaccination, use of systemic immunosuppressive medications (e.g. methotrexate or cyclosporine A) or a blood transfusion one month before screening
研究者
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