NCT05164939Unknown不适用
Precision Medicine Intervention in Severe Asthma (PRISM) Study: Molecular Phenotyping of Participants With Severe Asthma to Determine Response to Biologic Therapies and Stability
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Asthma exacerbations
研究概览
简要总结
The Korea-UK Precision Medicine Intervention in Severe Asthma (PRISM) study aims to identify molecular phenotypes of severe asthma by analyzing multi-omics data including genomics, epigenomics, transcriptomics, proteomics, metagenomics, and metabolomics.
详细描述
This is a prospective, observational cohort study. The participants are composed of the patients having severe asthma treated with biologic agents or conventional medication. Once enrolled, regular evaluation of clinical characteristics and obtainment of samples for omics analysis is conducted to identify clinically relevance molecular signals in severe asthmatics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject aged between 18 years and 80 years
- •Give written informed consent prior to participation in the study including all procedures
- •Comply with study protocol requirements
- •Able to read, comprehend, and write at a sufficient level to complete study related materials
- •Able to complete the study and all measurements
- •All patients have been through a severe asthma protocol that have ascertained the diagnosis of severe asthma, maximised treatments and ensured adherence to therapy.
- •Stable asthma therapy for at least a month before screening
排除标准
- •As a result of medical interview, physical examination or screening investigation the investigators consider the subject unfit either because of risk to the subject due to the study or the influence this may have on the study results.
- •A history of recreational drug use or allergy which in the opinion of the investigators contraindicates their participation.
- •Participation within 3 months in any a trial testing a new molecular entity or drug.
- •Those, in the opinion of the investigator, who may prove non-compliant with study procedures.
- •Within 4 weeks of screening visit been hospitalized or required high dose oral corticosteroid (>30 mg prednisolone per day) therapy, asthma not been stable.
- •Patients who have had prior treatment with bronchial thermoplasty, defined as completion of all thermoplasty treatment sessions within 6 months of screening
- •History of significant pulmonary disease other than severe asthma.
- •History of pulmonary eosinophilic syndrome or hyper eosinophilic syndrome.
- •History of bronchopulmonary aspergillosis
结局指标
主要结局
Asthma exacerbations
时间窗: baseline, 1month, 6month, 10 month
Changes of number of asthma exacerbations
次要结局
- Fraction of exhaled nitric oxide, FENO(baseline, 1month, 6month, 10 month)
- Induced sputum eosinophil(baseline, 1month, 6month, 10 month)
- Quality of Life Questionnaire(baseline, 1month, 6month, 10 month)
- Forced Exahled Volume in 1 second (FEV1)(baseline, 1month, 6month, 10 month)
- Rhinosinusitis symptoms(baseline, 1month, 6month, 10 month)
- Forced Vital Capacity (FVC)(baseline, 1month, 6month, 10 month)
- Asthma symptom control(baseline, 1month, 6month, 10 month)
- Blood eosinophils(baseline, 1month, 6month, 10 month)
研究者
Tae-Bum Kim
Professor
Asan Medical Center
研究点 (2)
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