Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Number of Exacerbations of the Participants
研究概览
简要总结
This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.
详细描述
The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS
排除标准
- •patients without asthma
研究组 & 干预措施
anti-IL5/IL5R-therapy group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R
干预措施: IL5 Antagonist or anti-IL5R-antibody or Omalizumab (Drug)
anti-IgE-therapy group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy
干预措施: IL5 Antagonist or anti-IL5R-antibody or Omalizumab (Drug)
结局指标
主要结局
Change in Number of Exacerbations of the Participants
时间窗: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)
Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.
次要结局
- Change in Oral Corticosteroid Dose in Milligrams(The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy")
- Change in the Number of Courses of Antimicrobics(The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals)
- Change in the Number of Emergency Room Visits of the Participants(The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals)
研究者
Paula Kauppi, MD, PhD
Chief Specialist of Allergy Department, Principal Investigator, Adj Prof.
Helsinki University Central Hospital