NCT05632081尚未招募不适用
Study of Mild and Moderate Asthma Step-up in Real Life as a New Endpoint (SURFE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Annualized frequency of asthma step-up
研究概览
简要总结
The goal of this observational study is to learn about the frequency needed for stepping-up treatment in patients with mild and moderate bronchial asthma. The main questions this study aims to answer are:
- What is the frequency and duration in which patients of asthma need to step up their treatment?
- Can the criteria described in this study be applied and validated to test need for step up of asthma treatment? Participants will follow the treatment they are already receiving according to established guidelines and will be asked for regular visits for examination and spirometry. They will record symptoms score, each time they use the prescribed rescu inhaler, and morning and evening peak expiratory flow.
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give written informed consent.
- •Age above 12 years.
- •Ability to use study inhalers correctly, use e-diary, and comply with study procedures and visits.
- •Confirmed diagnosis of mild or moderate asthma asthma (based on GINA defined asthma control on a maximum of maintenance low dose ICS/LABA combination).
- •Pre-bronchodilator ≥FEV1 60%.
- •Reversibility test ≥12% or 200 ml from baseline.
- •Non-smoker.
- •For female subjects, non-pregnant and administer efficient contraception if in childbearing period.
排除标准
- •Severe asthma exacerbation in last 3 months.
- •Use of any systemic corticosteroids in last 12 weeks.
- •Use of depot systemic steroids in last 12 weeks.
- •Any concurrent respiratory disease as bronchiectasis, COPD, lung fibrosis, ...
- •Current or known history of tuberculosis in any organ.
- •Current malignancy or any history of malignant disease for the past 5 years.
- •Subjects receiving any medications with known drug interaction with study medications.
- •Use of beta-blockers including eye drops.
- •Any significant concurrent disease as cardiac, hepatic, renal, ...
- •Current or history of alcohol or drug abuse.
- •Current or history of significant psychiatric disease.
- •Current or history of significant immunodefieciency.
- •History of receiving any biological therapy for asthma for the last 3 years or currently eligible for any biological therapy for asthma.
- •Subjects under any immuno-modulating therapy including biological therapy for any other indication. Subjects may be allowed to participate after 5 times half-live of the concerned drug.
- •Any known allergy or contraindication to any of the study medications.
结局指标
主要结局
Annualized frequency of asthma step-up
时间窗: 52 weeks
Event in which the patient is considered eligible for step-up of asthma therapy. Any of the following is considered as asthma step-up: 1. Use of reliever medication once daily or more for successive 7 days. 2. Use of reliever medication for 2 times or more for successive 3 days. 3. Any severe exacerbation as per protocol definition. 4. Increase in weekly ACQ-5 score (with higher score means worse asthma control) by 0.5 or more points. 5. Persistent decrease in PEF by 20% or more from baseline for 3 days or more.
次要结局
- Annualized frequency of asthma step-down.(52 weeks)
- Annualized rate of asthma severe exacerbation.(52 weeks)
- Annualized rate of asthma control weeks.(52 weeks)
研究者
Hesham Raafat
A. professor chest medicine department, pulmonology consultant
Ain Shams University
研究点 (1)
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