NCT02596321已完成3 期
A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With Allergic Rhinitis and/or Atopic Asthma Induced by House Dust Mites
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 112
- 试验地点
- 9
- 主要终点
- D. Farinae Specific IgG4 Change From Baseline to End of Treatment
研究概览
简要总结
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.
详细描述
To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days
To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo
To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo
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
- Triple (Participant, Care Provider, Investigator)
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 obtained before entering the study
- •Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year
- •Use of symptomatic treatment of HDM-induced allergic rhinitis and/or HDM-induced atopic asthma, i.e. antihistamines, nasal decongestants, nasal and/or inhaled corticosteroid for more than 1 year
- •if HDM-induced atopic asthma is present, it should be of mild to moderate severity, controlled on treatment corresponding to steps 1-3 of The Global initiative for asthma (GINA)
- •Positive skin prick test response (wheal diameter ≥3 mm) to D pteronyssinus and/or D.farinae
- •Moderate or higher level of D.pteronyssinus and/or D.farinae specific IgE (defined as ≥IgE Class 2; or ≥0.70 kilo unit (kU)/L)
- •Patient one of the following:
- •Female, infertile
- •Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with study drug has been discontinued.
- •Patient willing and able to comply with study protocol
排除标准
- •Previous treatment with HDM immunotherapy for more than 1 month within the last 5 years
- •Ongoing treatment with any allergen-specific immunotherapy product
- •Reduced lung function (defined as Forced expiratory volume in 1 second (FEV1) < 70% of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- •Clinical history of uncontrolled asthma within 3 months prior to the screening visit
- •Having experienced a severe asthma exacerbation within 3 months prior to screening visit
- •Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
- •Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomization
- •History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction)
- •History of recurrent generalized urticaria (defined as two or more episodes) during the last 2 years
- •A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
- •Any chronic disease (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 study evaluations or the safety of the subject)
- •Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
- •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
- •Currently treated with tricyclic antidepressants; catecholamine-O-methyltransferase (COMT) inhibitors and mono amine oxidase inhibitors (MAOIs) and beta-blockers including topical administration
- •Use of medication at the screening visit which at the time of skin prick test (SPT) can interfere with the result (i.e. antihistamines)
- •Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to the screening visit
- •History of allergy, hypersensitivity or intolerance to a excipient in the investigational medicinal product (except D.Pteronyssinus and D.farinae)
- •Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
- •Severe mental disorders that in the opinion of the investigator would interfere with the study evaluations or the safety of the subject
- •Cardiovascular conditions in which complications are possible when using adrenaline
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Mitizax ALK HDM tablet
Experimental
Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)
干预措施: Mitizax (Drug)
Placebo tablet
Placebo Comparator
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
D. Farinae Specific IgG4 Change From Baseline to End of Treatment
时间窗: 60 days from baseline
primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment
次要结局
- D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment(60 days from baseline)
- D. Farinae Specific IgE Change From Baseline to End of Treatment(60 days from baseline)
- D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment(60 days from baseline)
研究者
研究点 (9)
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