EUCTR2020-004328-41-PL进行中（未招募）1 期
A multicentre, randomized, open label clinical trial for the safety evaluation of a short dose escalation scheme using one strength for allergen immunotherapy with an aluminium-hydroxide adsorbed native allergen preparation of house dust mite allergens in adult and adolescent patients with moderate to severe allergic rhinitis or rhinoconjunctivitis with or without asthma. - TiME (short allergen immunotherapy mites)
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
- 140
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
- 性别
- All
入选标准
- •1. Written informed consent given from patient (and parents/legal guardian(s), as applicable)
- •2. Age between 12 and = 65 years
- •3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by house dust mite allergens (established and documented as part of the screening procedures)
- •4. Symptoms of allergic rhinitis or rhinoconjunctivitis triggered by house dust mite exposure over at least the last 2 years
- •5. No diagnosis of bronchial asthma in medical history, or confirmed diagnosis of asthma as being well controlled”
- •6. Previous symptomatic anti-allergic treatment for at least 2 years prior to enrolment
- •7. Negative SARS-CoV-2 test result
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •General criteria:
- •1. Patients and if relevant parents/legal guardian(s) are unable to understand and comply with the requirements of the trial, as judged by the investigator
- •2. Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
- •3. Low adherence to trial procedures expected or inability to understand instructions/trial documents by participant and/or parents/legal guardian(s)
- •4. Involvement in the planning and conduct of the trial
- •5. Patients and if relevant parent/legal guardian is employee of Allergopharma GmbH & Co. KG or of one of the trial sites or CRO
- •6. Any relationship of dependence with the sponsor or with the investigator
- •7. Previous randomization to treatment in the present trial
- •8. Mentally disabled
- •9. Institutionalized due to an official or judicial order
- •For female patients with childbearing potential
- •10. Positive urine pregnancy test or pregnant
- •11. Wish to become pregnant during the course of the trial
- •12.Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
- •13. Wish to breast feed or breast feeding
- •Immunotherapy criteria:
- •14. History of a confirmed anaphylaxis after an AIT injection
- •15. AIT with house dust mite allergoids or allergens within the last 5 years
- •16. Current treatment with any kind of allergen immunotherapy (AIT)
- •17. AIT with unknown allergen within the last 5 years Diseases and health status:
- •18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
- •19. Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to
- •GINA recommendation (GINA 2020)
- •20. Uncontrolled or partly controlled asthma according to GINA recommendation (INA 2020)
- •21. Acute asthma attack within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency visit
- •22. Severe acute or chronic diseases (e.g. COVID-19, chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys), acute viral and bacterial infections presenting with fever
- •23. Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease, multiple sclerosis)
- •24. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •25. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy)
- •26. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
- •27. For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patient.
- •Medications:
- •28. Use of ß-blockers (locally or systemically), ACE inhibitors
- •29. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heartdisease, severe hypertension)
- •30. Completion or ongoing treatment with anti-IgE-a
研究者
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