EUCTR2016-004363-39-GB进行中（未招募）1 期
A phase III trial evaluating the efficacy and safety of the house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in children and adolescents (5-17 years) with HDM allergic asthma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •I1. Written informed consent obtained from parents/caregivers before any trial related procedures are performed. Consent or assent from the
- •subject must be obtained according to national requirements. Footnote: At least one parent/caregiver must be able to read.
- •I2. Male or female of any race/ethnicity aged =4 to =17 years on the day informed consent is obtained from the parent/caregiver. The subject must be =5 to =17 years old at the randomisation visit
- •I3. A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until the follow-up TC
- •I4. A clinical history of HDM allergic asthma of at least 1 year duration diagnosed by a physician
- •I5. Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms within the past year prior to randomisation. For definition of ICS doses, please see Table 3 and Table 4
- •I6. =3 clinically relevant asthma exacerbations in the past two years or =2 clinically relevant asthma exacerbations in the past year or =1 severe asthma exacerbation in the past year prior to randomization while being on asthma controller medication (low dose ICS plus LABA or medium/high dose ICS with or without LABA) . The asthma controller medication at the screening visit must be at a dose equivalent to or below the dose the subject received before the last asthma exacerbation occurred
- •I7. One or more of the following within the past 4 weeks prior to randomisation:
- •a. Daytime asthma symptoms more than twice/week
- •b. Any nocturnal awakening due to asthma which require use of SABA rescue medication
- •c. SABA rescue medication needed for treatment of asthma symptoms more than twice/week
- •d. Any activity limitation due to asthma
- •I8. Lung function measured by FEV1 = 70% of predicted value or according to local requirements while on background treatment following at least a 6-hour washout of SABA at screening and randomisation
- •I9. Clinical history of HDM AR within the last year prior to randomisation
- •I10. An average TCRS>0 during the baseline period (period 2)
- •I11. Positive specific IgE (defined as =class 2, =0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
- •I12. Positive SPT to D. pteronyssinus and/or D. farinae at screening
- •I13. Subject willing and able to comply with trial protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 600
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •E1. Has a clinically relevant history and is sensitised, symptomatic and regularly exposed to animal dander, molds, and/or cockroach (e.g., present in the home, job, school, etc.) or other perennial allergen
- •E2. Has experienced a life-threatening asthma attack defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilator support
- •E3. Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- •E4. Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- •E5. SLIT treatment with D. pteronyssinus or D. farinae for more than 1 month within the last 5 years. In addition, any SLIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
- •E6. SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
- •E7. Ongoing treatment with any allergy immunotherapy product
- •E8. Severe chronic oral inflammation
- •E9. Any nasal or naso/oropharyngeal condition that could confound the efficacy or safety assessments (e.g., hypertrophy of the pharyngeal/palatine tonsils, clinically relevant nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinates)
- •E10. Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
- •E11. Has a diagnosis or history of eosinophilic oesophagitis
- •E12. A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
- •E13. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance
- •E14. Ongoing treatment with OCS
- •E15. Treatment with restricted and prohibited concomitant medication listed in Table 2
- •E16. Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
- •E17. A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
- •E18. A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
- •E19. A history of alcohol or drug abuse
- •E20. Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
研究者
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