The Impact of Anxiety/Depression on the Efficacy of Asthma Control Drugs and the Construction of a Predictive Model for the Risk of Acute Asthma Attacks
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Acute asthma attack
研究概览
简要总结
The goal of this clinical trial is to explore the impact of anxiety/depression on the efficacy of asthma controller medications and to develop a risk prediction model for asthma acute exacerbations in patients with asthma. It will also analyze the association between anxiety/depression severity and asthma severity. The main questions it aims to answer are:
Does anxiety/depression affect the therapeutic effect of asthma controller medications (e.g., asthma control level)? Can a reliable risk prediction model for asthma acute exacerbations be established based on anxiety/depression and other relevant factors? Researchers will conduct a prospective observational study to collect and analyze data from participants, without additional interventions beyond standard clinical care, to explore the above research questions.
Participants will:
Complete baseline assessments, including demographic information collection, medical history review, lung function tests, anxiety/depression evaluations (via GAD-7 and PHQ-9 scales), and provide biological samples (induced sputum, feces, blood) Undergo follow-up visits at 3, 6, 12, 18, and 24 months after baseline Report asthma symptoms, acute exacerbation events, and cooperate with required clinical checkups during follow-up
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma according to the Global Initiative for Asthma (GINA) 2024 criteria.
- •Male or female patients aged 14 years or older.
- •Complete clinical data available.
- •Newly diagnosed asthma or stable asthma.
- •Receiving asthma controller medication.
排除标准
- •History of major lung diseases other than asthma, congestive heart failure, cor pulmonale, or recent cardiac or thoracic surgery.
- •Incomplete medical records.
- •Cognitive impairment or inability to complete psychological scale assessments.
- •Clinically diagnosed acute or chronic mental disorders, such as bipolar disorder or schizophrenia.
- •Current use of antidepressant or anti-anxiety medications.
- •Pregnancy or lactation.
结局指标
主要结局
Acute asthma attack
时间窗: 1 year
Number of acute asthma attacks in patients during follow-up period
次要结局
未报告次要终点
研究者
Yuanyuan Li
Chief Physician
Xiangya Hospital of Central South University