Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- CSMS
研究概览
简要总结
A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/=
- •informed consent
排除标准
- •chronic rhinosinusitis with or without nose polyps
- •Previous immunotherapy (SLIT or SCIT)
- •BMI > 35
- •house dust mite allergy with symptoms
- •allergy towards furry animals if exposition cannot be avoided
- •25(OH)Vitamin D levels < 25 or > 75 nmol/L
- •use of Vitamin D supplementation or excessive use of sun tanning booths
- •mental incapacity to follow study protocol
- •other significant disease
- •allergy towards study medication
- •uncontrolled asthma
- •severe atopic dermatitis
- •pregnancy or nursing
- •autoimmune disease
- •hyper IgE-syndrome
- •cardiovascular disease
- •lung disease
- •liver or kidney disease
- •hematologic disorder
- •metabolic disease
- •chronic infectious disese
- •medications interacting with the immune system
- •previous cytostatic therapy
- •medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment
- •drug or alcohol abuse
- •intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1
- •withdrawn consent
- •Exclusion Criteria only for ILIT group (due to vitamin D treatment)
- •medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics)
- •tendency for formation of kidney stones
- •hyperparathyroidism or other disease conferring risk of hypercalcemia
- •hereditary pseudohypoparathyroidism with decreased phosphorous secretion
- •malabsorption or bowel disease with diarrhea
- •Mb Paget, osteoporosis or sarcoidosis
- •skin disease at the groin (where the treatment will be injected)
研究组 & 干预措施
SLIT
Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years
干预措施: SLIT Grazax ALK Nordic 75 000 SQ-T (Drug)
ILIT + Vitamin D
Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
干预措施: ILIT + Vitamin D (Drug)
ILIT + placebo
Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
干预措施: ILIT + placebo (Drug)
结局指标
主要结局
CSMS
时间窗: 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.
Daily Combined Symptoms and Medication Scores (0-3)
次要结局
- RQLQ(60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.)
- CSMS peak pollen season(15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.)
- Serolology with immunoglobulins(1 year before treatment, 4-6 weeks after treatment, 1 year after treatment)
- VAS (0-10)(4-6 months before treatment and 6-9 months after treatment)
研究者
Lars Olaf Cardell
Professor
Karolinska Institutet