NCT02166268已完成2 期
Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Average total nasal symptom score
研究概览
简要总结
The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of rhinitis in an environmental challenge chamber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female aged 18 to 65 years
- •The subject fulfills one of the following criteria:
- •Female, infertile
- •Female of child-bearing potential, with a negative pregnancy test
- •Moderate-to-severe grass pollen induced rhinoconjunctivitis
- •Positive skin prick test response (wheal diameter ≥ 3 mm) to Phleum pratense
- •Positive specific Immunoglobulin E (IgE) against Phleum pratense (≥ IgE Class 2; ≥0.70 kilo Unit/L)
- •Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a total nasal symptom score of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC visit
- •The subject must be willing and able to comply with the trial protocol
排除标准
- •Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate
- •Rhinoconjunctivitis caused by animal hair and dander, house dust mites and moulds
- •Clinical history of uncontrolled asthma within 3 months prior to screening
- •Subjects with reduced lung function forced expiratory volume in 1 second <70% of the predicted value after adequate pharmacologic treatment
- •Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
- •Previous treatment with immunotherapy to a grass pollen allergen or a cross reacting allergen within the past 5 years
- •Ongoing treatment with any allergen-specific immunotherapy product
- •Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation and at the baseline challenge
- •Clinically relevant nasal polyps
- •History of paranasal sinus surgery
- •History of surgery of nasal turbinates
- •History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction)
- •History of recurrent (defined as 2 or more episodes) generalised urticaria during the last 2 years
- •History of drug-induced (including immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
- •Any clinically relevant chronic disease (≥3 months duration) (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality, or any other diseases that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subjects)
- •Systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease)
- •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
- •Currently treated with tricyclic antidepressants, catecholamine-O
- •methyltransferase inhibitors and/or mono amine oxidase inhibitors
- •Treatment with antidepressant medication with antihistaminic effect (e.g. doxepin, mianserin)
- •Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, thioridazine)
- •Treatment with anti-IgE drugs (e.g. omalizumab) within 130 days/5 half-lives which ever longest
- •Treatment with systemic and/or topical β-blockers
- •Use of an investigational drug within 30 days/5 half-lives of the drug, which ever the longest, prior to screening
- •History of allergy, hypersensitivity or intolerance to an excipient the investigational drug (except Phleum pratense)
- •Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent, or grandchild
- •History of alcohol or drug abuse
研究组 & 干预措施
Avanz Phleum pratense
Active Comparator
Avanz Phleum pratense 15,000 SQ+ (standardised quality), suspension for subcutaneous injection.
干预措施: AVANZ Phleum pratense 15,000 SQ+ (Drug)
Placebo
Placebo Comparator
Placebo, suspension for subcutaneous injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Average total nasal symptom score
时间窗: After 1-year of treatment
The Total Nasal Symptom Score consist of 4 symptoms: runny nose, blocked nose, sneezing and itchy nose scored on a scale form 0-3. Measured during the final Environmental challenge chamber (ECC) visit.
次要结局
- Total nasal symptom score collected at the 2nd ECC visit(After 16 weeks of treatment)
- Average Total Symptom Score(Meaured after 16 weeks and 1 year of treatment.)
- Treatment emergent adverse events(During the 1-year treatment period with Avanz)
研究者
研究点 (1)
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