EUCTR2017-003063-34-DE进行中（未招募）1 期
A double-blind, placebo-controlled dose-escalation study of carbamylated monomeric tree pollen drops in patients with a history of allergic rhinoconjunctivitis.
ofarma S.p.A.0 个研究点目标入组 48 人开始时间: 2017年9月1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
- 48
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 signifcant 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:
- •A medical history of moderate to severe allergic rhinoconjunctivitis for birch pollen allergens for at least 2 years (definition of allergy severity according to ARIA (Bousquet et al., 2001))
- •A positive skin prick test (SPT, wheal diameter =3 mm) to birch pollen allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal <2 mm
- •Specific IgE against birch pollen allergens (Bet v1) =0.7 kU/L
- •Positive response to conjunctival provocation test with at least a 1/10 dilution from a birch allergen provocation test stock solution
- •Being treated with anti-allergic medication for at least 2 seasons prior to enrolment
- •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 48
- •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 birch pollen allergens within the last 5 years
- •Ongoing immunotherapy with birch 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 or placebo
- •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.hazel) 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
- •Moderate to severe oral allergy syndrome caused by tree pollen-food cross-reactivity
- •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
- •General inflammatory, severe, acute or chronic inflammatory diseases
- •Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
- •Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
- •Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
- •Use of systemic beta-blockers
- •Active tuberculosis
- •Contraindication for the use of adrenaline (including hyperthyroidism)
- •Contraindication for CPT (eye diseases except for anomalies of refraction, active allergic conjunctivitis, contact lenses, antiallergic therapy)
- •Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
- •Females who are pregnant, lactating, or of child-bearing potential and not using adequate contraceptives
- •Use of corticosteroids (oral, topic or nasal) or anti-histaminic drugs before screening visit. Exception made for routine medication for asthma control in asthmatic patients
- •Planned vaccination during the study (e.g. against flu, pneumococae, etc.)
- •Clinically relevant laboratory values, i.e. grade =2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007)
- •Patients, who the Investigator believes will not comply with the study protocol (patients with alcohol/drug abuse, history of serious psychiatric disorder, or who unwilling to give informed c
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