EUCTR2018-001339-33-NL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, study to determine the added value of vitamin D3 to treatment with subcutaneous immunotherapy in patients with moderate to severe allergic rhinitis/ rhinoconjunctivitis caused by birch pollen - SCITVITD3
Academisch medisch centrum Amsterdam0 个研究点目标入组 40 人开始时间: 2018年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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.Signed informed consent
- •2.Age =18 = 65 years
- •3.Moderate to severe birch-pollen-induced AR/ARC of at least 2 years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (Appendix 1, see manual) with or without concomitant mild to moderate persistent asthma
- •4.FEV1>70% for patients with a history of asthma, FEV1>70% or PEF>80% for patients without a history of asthma
- •5.A positive SPT (mean wheal diameter = 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization
- •6.A positive ImmunoCAP (>0.7 kU/L) for birch pollen
- •7.A positive tNPT (for rules when a tNPT is positive see ref 40a)
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Clinically relevant co-sensitization (others than hazel, alder and elm) expected during the birch-pollen season.
- •2.Chronic asthma with an FEV1<70 % of predicted value.
- •3.History of AIT (SCIT or SLIT) with any allergen within the past 5 years
- •4.Ongoing AIT (SCIT or SLIT) with any allergen(s) during the study period
- •5.Current Treatment with VD3 analogue.
- •6.Vaccination within one week before or during the treatment phase.
- •7.Immunosuppressive or biological medication (e.g. IL-5, anti-IgE therapy) within the last six months prior to inclusion and up to end of trial (EoT).
- •8.Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
- •9.Uncontrolled asthma or other active respiratory diseases.
- •10.Active malignancies or any malignant disease during the previous 5 years.
- •11.Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders.
- •12.Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study.
- •13.Moderate to severe nasal obstructive diseases that preclude a TNPT (e.g., septal deviation, nasal polyps) or nasal/sinus surgery in the last 3 months.
- •14.Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
- •15.Use of systemic steroids within 4 weeks before start of the study and during the study.
- •16.Treatment with systemic and local ß-blockers.
- •17.Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or oral contraceptive pill).
- •18.Alcohol, drug or medication abuse within the past year.
- •19.Any clinically significant abnormal laboratory parameter at screening.
- •20.Lack of cooperation or compliance.
- •21.Any physical or mental condition that precludes administration of SCIT, compliance or participation in a clinical trial.
- •22.Patients who are students or employees of the institution or 1st grade relatives or partners of the investigators
- •23.Participation in a clinical trial within 3 months prior to the current trial.
研究者
相似试验
进行中（未招募）
1 期
Investigating otilimab in patients with severe coronavirus related lung disease.Severe pulmonary COVID-19 related diseaseMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001759-42-BEGlaxoSmithKline Research & Development Limited1,150
尚未招募
Unknown
A randomized, double-blind, placebo-controlled, parallel study with an open label placebo extensioCTRI/2023/05/052481Vidya Herbs Pvt Ltd
进行中（未招募）
1 期
Investigating otilimab in patients with severe coronavirus related lung disease.Severe pulmonary COVID-19 related diseaseMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001759-42-NLGlaxoSmithKline Research & Development Limited1,150
进行中（未招募）
1 期
Investigating otilimab in patients with severe coronavirus related lung disease.Severe pulmonary COVID-19 related diseaseMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001759-42-ITGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT1,156
进行中（未招募）
1 期
Investigating otilimab in patients with severe coronavirus related lung disease.Severe pulmonary COVID-19 related diseaseMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001759-42-DEGlaxoSmithKline Research & Development Limited1,150