EUCTR2018-000548-25-PL进行中（未招募）1 期
A multicentre, randomized, open label clinical trial for safety evaluation of an accelerated high dose escalation schedule with one strength for an allergen immunotherapy with an aluminium hydroxide adsorbed allergoid preparation of 6-Grasses in pediatric patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without asthma - ONSeT jun
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) 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. Age between 5 to < 18 years
- •3. IgE-mediated seasonal moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by grass pollen documented by:
- •Skin prick test (SPT):
- •wheal for grass pollen = 3 mm in diameter
- •Histamine wheal = 3 mm (positive control)
- •NaCl reaction < 2 mm (negative control)
- •Assessment of moderate to severe rhinitis according to ARIA guideline (Brozek et al. 2010)
- •Immunoassay result for specific IgE = 0.70 kU/L to grass pollen
- •4. At least 1 month symptoms of allergic rhinitis or rhinoconjunctivitis in May to August triggered by grass pollen exposure over the last two seasons.
- •5. In case of bronchial asthma at entry: confirmed diagnosis of asthma according to GINA guideline (GINA 2017)
- •6. In case of a diagnosed asthma: asthma symptoms classified as being well controlled” according to GINA guideline (GINA 2017)
- •7. Previous treatment with anti-allergic treatment for at least 2 seasons prior to enrolment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •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
- •General criteria:
- •1. 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 any other clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
- •3. Low compliance or inability to understand instructions/trial documents by parents/legal guardian(s)
- •4. Involvement in the planning and conduct of the trial
- •5. Parent/legal guardian is 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. 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 pregnancy test or pregnant
- •11. Use of an unacceptable or unreliable contraceptive method during the trial, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate less than 1% per year)
- •12. Wish to breast feed or breast feeding
- •13. Wish to become pregnant during the course of the trial
- •Immunotherapy criteria:
- •14. History of a confirmed anaphylaxis after an AIT injection
- •15. AIT with grass pollen within the last 5 years
- •16. Current treatment with any kind of immunotherapy
- •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 guidelines (GINA 2017)
- •20. Uncontrolled or partly controlled asthma according to GINA guidelines (GINA 2017)
- •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. chronic urticaria, mastocytose, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
- •23. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced 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 beta-blockers (locally or systemically), ACE inhibitors
- •29. Contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)
- •30. Completion or ongoing treatment with anti-IgE-antibody
- •31. Completion or ongoing long-term treatment with tranquilizer or other psychoactive drugs
研究者
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