Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mean Combined Medical- and Symptom score (CSMS)
研究概览
简要总结
This study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.
详细描述
The study was an interventional single center double-blinded human randomized trial with two groups treated parallel.The first group received an intramuscular injection of Methylprednisolone 40 mg/ml 2ml x 1 as a single dose. The second group received an intramuscular injection of NaCl 0,9 mg/ml 2ml x 1 as a single dose. Symptom score and the use of medication was registered daily during the pollen peak of the season, using an electronic diary. The study was conducted during the spring of 2019.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe birch pollen induced allergic rhinitis.
- •Signed informed consent according to International Council of Harmonisation/Good Clinical Practice, and national/local regulations.
- •Women of considered childbearing potential (WOCBP) will only be included after a negative highly sensitive pregnancy test according to CTFG recommendations.
排除标准
- •Pregnancy or nursing.
- •Autoimmune or collagen disease.
- •Cardiovascular disease.
- •Hepatic disease.
- •Renal disease.
- •Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive- and restrictive lung disease).
- •Medication with a possible side-effect of interfering with the immune response.
- •Previous immuno- or chemotherapy.
- •Chronic disease.
- •Major metabolic disease.
- •Alcohol or drug abuse.
- •Mental incapability of coping with the study.
- •Known or suspected allergy to the study product.
- •Suspicion of or confirmed bacterial infection.
- •Known allergy to the study drugs, "rescue medication".
研究组 & 干预措施
Methylprednisolone
Depo-Medrol (Methylprednisolone) 40 milligrams/milliliter, 2 milliliters as a single dosage
干预措施: MethylPREDNISolone 40 Mg/mL Injectable Suspension (Drug)
Sodium Chloride (NaCl)
NaCl 0,9 milligrams/milliliter, 2 milliliters as a single dosage
干预措施: NaCl 9 MG/ML Injectable Solution (Drug)
结局指标
主要结局
Mean Combined Medical- and Symptom score (CSMS)
时间窗: 3 weeks
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms) and use of rescue medication (3-point scale. 0=no medication, 1= oral and/or topical (eyes) non sedative H1 antihistamines (H1A), 2= intranasal corticosteroids with/without H1A) during the birch pollen season. CSMS 6-point scale (0=no symptoms and no use of medication, 5= severe symptoms and use of intranasal corticosteroids with/without H1A)
Mean symptom score
时间窗: 3 weeks
Daily scoring of rhinoconjunctivitis symptoms (4 questions, 4-point scale. 0= no symptoms and 3=severe symptoms)
次要结局
- Effects on Quality of Life (QoL), SNOT(3 weeks)
- Effects on Quality of Life (QoL), RQLQ(3 weeks)
- Effects on Quality of Life (QoL), ACQ(3 weeks)
研究者
Lars Olaf Cardell
Professor, MD
Karolinska Institutet