EUCTR2015-000188-15-PL进行中（未招募）1 期
A multicenter randomized double-blind placebo-controlled clinical trial for evaluation of efficacy and safety of specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with allergic bronchial asthma and with allergic rhinitis or rhinoconjunctivitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,390
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
- •1. Written informed consent and assent according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
- •2. Male or female outpatient between 12 and 65 years (both inclusive), but Italy and Russia: 18 - 65 years only
- •3. IgE-mediated allergic bronchial asthma treated according GINA step 2-4 with rhinitis or rhinoconjunctivitis induced by house dust mite documented by
- •SPT wheal for D p = 3 mm in diameter
- •histamine (0.1% histamine) wheal = 3 mm
- •a negative control reaction (NaCl) wheal < 2 mm
- •Immunoassay result specific IgE > 1.5 kU/L to D p
- •symptoms of asthma and rhinitis or rhinoconjunctivitis e.g. during the months September to February or over the entire year
- •4. confirmed diagnosis of asthma
- •treatment according to GINA 2016 during the last year as documented by requirement of ICS and in addition, either the requirement of a long acting bronchodilator or as-needed of a short acting bronchodilator
- •FEV1 increase of = 12% and 200 mL of the baseline FEV1 after inhalation of 400µg of Salbutamol or other short acting bronchodilator equivalent (historical data not older than 2 years are acceptable. A methacholine test (
- •= 20% FEV1 decrease after Methacholine provocation test) in the historical data is acceptable)
- •Achievement of asthma control criteria (ACQ6 = 1.0 scores in 2 consecutive weeks at the end of the assessment period) during the baseline diary phase within a required ICS dose between 400 to 1200 µg Budesonide per day
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 133
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 313
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General criteria:
- •1. Unable to understand and comply with the requirements of the trial, as judged by the investigator
- •2. Currently participating in any other trial or in participating in any other trial within 30 days before inclusion in this trial
- •3. Low compliance, persistent incorrect inhaler technique as assessed by the investigator or inability to understand instructions or trial documents
- •4. Involved in the planning and conduct of the trial
- •5. Employee of Allergopharma GmbH & Co. KG or of one of the trial sites
- •6. Any relationship of dependence with the sponsor or with the investigator
- •7. Previously enrolled or randomized to treatment in the present trial
- •8. Mentally disabled
- •9. Institutionalized due to an official or judicial order
- •For females with childbearing potential (i.e. females who are not chemically or surgically sterilized or females who are not post-menopausal [defined as 12 months with no menses without an alternative medical cause]:
- •10. Positive pregnancy test
- •11. Use of an unacceptable or unreliable contraceptive method as judged
- •by the investigator (reliable and highly effective methods of birth control
- •defined as failure rate less than 1% per year [CTFG recommendations 15
- •Sep 2014]) during the trial. Sexual abstinence is an allowed method of
- •birth control (sexual abstinence is considered a highly effective method
- •only if defined as refraining from heterosexual intercourse during the
- •entire period of risk associated with the study treatments. The reliability
- •of sexual abstinence needs to be evaluated in relation to the duration of
- •the clinical trial and the preferred and usual lifestyle of the subject.)
- •Males are not required to use any contraception during the study.
- •12. Pregnant, breast feeding or wishes to breast feed
- •13. Seeking to become pregnant during the course of the trial
- •Immunotherapy criteria:
- •14. Any AIT with house dust mites
- •15. Current treatment with any kind of immunotherapy
- •16. Any AIT with unknown allergen
- •17. Clinically relevant symptoms to perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are symptoms to allergens of cat and dog, if the patient has no direct contact to these animals.
- •18. Sensitization in the immunoassay = 0.7 kU/L against perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are sensitizations to storage mites if the sensitization assessed by immunoassay is lower than the sensitization to at least one of the house dust mites (D p or D f). Exceptions are sensitizations assessed by immunoassay to cat and dog, if the patient has no direct contact to these animals.
- •Diseases and health status:
- •19. Clinically relevant rhinitis or respiratory symptoms related to other reasons (e.g. chronic sinusitis, COPD)
- •20. FEV1 < 70% of predicted normal (ECSC) at best asthma control status
- •21. Chronic, persistent
研究者
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