EUCTR2010-018621-19-GB进行中（未招募）1 期
Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma. - The MITRA trial.
ALK-Abello A/S0 个研究点目标入组 0 人开始时间: 2010年6月18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
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
入选标准
- •Subjects who meet each of the following criteria are eligible for the trial:
- •1. Written informed consent obtained before entering the trial.
- •2. Male or female = 18 years.
- •3. A clinical relevant history consistent with HDM induced asthma of at least 1 year prior to trial entry.
- •4. Use of asthma medication (e.g. combination products) for the control of asthma symptoms for a period of at least 6 months within the past year.
- •5. Dose of ICS after switching should at randomisation be in a range of budesonide 400-800 mcg.
- •6. Documented reversible airway obstruction as judged by one of the following criteria:
- •a) Improvement in absolute FEV1 = 12% and 200 ml after administration of SABA.
- •b) Improvement in PEF > 20% after administration of SABA.
- •c) Diurnal variability in PEF > 20% after administration of SABA.
- •d) Bronchial provocation test:
- •1. A decrease in FEV1 > 15% after 6 min of sustained exercise.
- •2. A decrease in FEV1 = 10% from baseline is recorded after a 6 minutes period of hyperpnea in dry air.
- •3. A decrease in FEV1 = 15% from baseline or = 10% from value obtained after the previous dose after mannitol inhalation challenge.
- •4. A decrease in FEV1 = 20% from baseline after methacholine inhalation challenge.
- •7. Asthma control level above or equal to 1.0 (ACQ = 1.0) at visit 1 (screening).
- •8. Asthma control level between 1.0 and 1.5 (1.0 = ACQ = 1.5) at visit 3 (randomisation).
- •9. Electronic diary compliance rate between visit 2 and visit 3 = 80% at visit 3 (randomisation).
- •10. FEV1 > 60% of predicted value.
- •11. A clinical history consistent with mild to severe HDM induced allergic rhinitis for at least 1 year.
- •12. Positive SPT response (wheal diameter = 3 mm larger than the negative control) to Der pte or Der far.
- •13. Positive specific IgE against Der pte or Der far (= IgE Class 2; = 0.70 KU/L).
- •14. Female subjects, who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods throughout the trial.
- •15. Subject willing and able to comply with trial protocol regimens.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who meet one or more of the following criteria are excluded from the trial:
- •1. A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except HDM).
- •2. A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period of the year corresponding the ICS reduction period (period 3).
- •3. Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
- •4. A clinical history of chronic sinusitis (> 3 months).
- •5. Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.
- •6. Current or previous use of any medication as specified in the protocol.
- •7. Symptoms of or treatment for upper respiratory tract infection, or other relevant infectious process at randomisation.
- •8. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
- •9. Physical examination with clinically relevant findings.
- •10. History of systemic allergic reaction with cardiorespiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction).
- •11. History of recurrent urticaria during the last 2 years.
- •12. A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents or siblings) history of hereditary angioedema.
- •13. Any clinically relevant chronic disease (= 3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
- •14. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
- •15. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit (except steroids for allergy and asthma symptoms).
- •16. History of allergy, hypersensitivity or intolerance to IMPs (except Der pte or Der far) or symptomatic medications.
- •17. Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
研究者
相似试验
进行中（未招募）
不适用
To find out if people with allergic asthma caused by house dust mites will benefit from allergy vaccine given as a tablet.House dust mite induced allergic asthmaMedDRA version: 13.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018621-19-NLALK-Abelló A/S800
进行中（未招募）
不适用
To find out if people with allergic asthma caused by house dust mites will benefit from allergy vaccine given as a tablet.House dust mite induced allergic asthmaMedDRA version: 13.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018621-19-DKALK-Abelló A/S800
进行中（未招募）
1 期
Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma. The MITRA Trial. - MITRAHouse dust mite induced allergic asthmaMedDRA version: 12.1Level: LLTClassification code 10001705Term: Allergic asthmaEUCTR2010-018621-19-SKALK-Abelló A/S800
进行中（未招募）
不适用
To find out if people with allergic asthma caused by house dust mites will benefit from allergy vaccine given as a tablet.House dust mite induced allergic asthmaMedDRA version: 14.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018621-19-ATALK-Abelló A/S800
进行中（未招募）
不适用
To find out if people with allergic asthma caused by house dust mites will benefit from allergy vaccine given as a tablet.House dust mite induced allergic asthmaMedDRA version: 14.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-018621-19-LVALK-Abelló A/S800