The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in Symptoms Score After Nasal Allergen Challenge
研究概览
简要总结
The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy given to adolescents and young adults who are allergic to grass or birch pollen and have mild or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving treatment will be given a fourth injection one year after the initial injections. The study is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin (Pediatrics) and prof Marianne van Hage (Immunology)".
详细描述
30 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses / birch or placebo. The patients receiving treatment will be given a fourth injection one year after the initial injections.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinitis due to grass or birch pollen
- •Mild to moderate asthma with a positive methacholine challenge
- •Accepted and signed informed consent.
排除标准
- •Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
- •Previously SCIT but no symptom improvement at all.
- •Sensitizations to house dust mite or furry animals, with ongoing exposure and symptoms.
- •Severe atopic dermatitis.
- •Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- •Patients with a respiratory tract infection in the past 4 weeks prior to Visit
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
- •Known autoimmune or collagen disease
- •Cardiovascular disease
- •Hepatic disease
- •Known renal insufficiency
- •Hematologic disease
- •Chronic infectious disease
- •Any medication with a possible side-effect of interfering with the immune response
- •Previous immuno- or chemotherapy
- •Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
- •Major metabolic disease
- •Known or suspected allergy to the study product
- •Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
- •Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit
- •Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit
- •Mental incapability of coping with the study
- •Withdrawal of informed consent
研究组 & 干预措施
Placebo
ALK diluent 0,3% human albumin'
干预措施: ALK diluent 0,3% human albumin (Drug)
Active treatment
Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension
干预措施: ALK Alutard birch or 5-grasses (Drug)
结局指标
主要结局
Change in Symptoms Score After Nasal Allergen Challenge
时间窗: At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).
0,1 ml of ALK Aquagen birch or timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. Symptoms during NPTs were scored according to the Lebel scoring scale. Symtom scores at 5, 15, and 30 minutes after nasal administration of the allergenextract were summed to represent the symptom-score at each nasal challenge (at inclusion, 12 months after inclusion and for the active patients 24 months after inclusion). The scoring system identifies nasal, eye, and ear symptoms: rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, watery eyes, and itchy ears, each graded on a scale from 0 to 3 points, and a total score was summarized after subtracting the starting score (min score is 0 and maximum score is 54 + the number of sneezes). Higher scores mean worse outcome.
次要结局
- Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Change in Pulmonary Function Measurement (Spirometry)(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Change in Quality of Life(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Change in Asthma Symptom Scores(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Change on Visual Analogue Scale (VAS(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Change in Symptom and Medication-score(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
- Changes in Response to a Bronchial Challenge With Methacholine(At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).)
研究者
Gunilla Hedlin
Professor
Karolinska Institutet