NCT01308021已完成2 期
Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis
BioTech Tools S.A.37 个研究点 分布在 3 个国家目标入组 202 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 37
- 主要终点
- Impact of gpASIT+TM on the clinical efficacy of the subjects
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years
- •Subject has given written informed consent
- •The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- •Male or non pregnant, non-lactating female
- •Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy > 2 years
排除标准
- •Subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years
- •Subjects with perennial asthma
- •Subjects with a VC < 80% and FEV1 < 70%
- •Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- •Documented evidence of chronic sinusitis (as determined by investigator)
- •Subjects with a history of hepatic or renal disease
- •Subjects symptomatic to perennial inhalant allergens
- •Subject with malignant disease, autoimmune disease
- •Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD, ...)
- •Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc...)
- •Subjects requiring beta-blockers medication
- •Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
- •Subject with febrile illness (> 37.5°C, oral)
- •A known positive serology for HIV-1/2, HBV or HCV
- •The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
- •Receipt of blood or a blood derivative in the past 6 months preceding trial entry
- •Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
- •Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
- •Use of long-acting antihistamines
- •Any condition which could be incompatible with protocol understanding and compliance
- •Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
- •Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
- •Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years
- •A history of hypersensitivity to the excipients
- •Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent...)
- •Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
结局指标
主要结局
Impact of gpASIT+TM on the clinical efficacy of the subjects
时间窗: grass pollen season 2011 (April to July)
The following parameter will be assessed: rhinoconjunctivitis total symptom score
次要结局
- Clinical tolerability and safety of the treatment(8 months)
- Impact of gpASIT+TM on the immunological status of the subjects(screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011))
- Impact of gpASIT+TM on the clinical status of the subjects(grass pollen season 2011 (April-July))
- Impact of gpASIT+TM on the quality of life of the subjects(grass pollen season 2011 (April-July))
研究者
研究点 (37)
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