Study on the Correlation Between Metabolomics and Anxiety and Depression in Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Frequency of acute exacerbations of bronchiectasis
研究概览
简要总结
Bronchiectasis is a common lung disease. Approximately 20-40% of patients with bronchiectasis experience comorbid anxiety and depression. Multiple studies have now demonstrated that anxiety and depression are associated with an increased risk of disease exacerbation in these individuals.
Therefore, this study aims to collect data on anxiety and depression status, disease exacerbation frequency, hospitalisation rates, and mortality among participants diagnosed with bronchiectasis. Concurrently, biological samples including blood, sputum, and stool will be obtained. Through metabolomics analysis, we will investigate the expression of anxiety and depression-related metabolic pathways and identify corresponding biomarkers to explore their role in the progression of bronchiectasis.
详细描述
Non-cystic fibrosis bronchiectasis is a common pulmonary disorder. Recurrent acute exacerbations of bronchiectasis can severely impair lung function, accelerate the decline of pulmonary capacity, diminish quality of life and shorten survival duration. While previous studies have identified factors such as deteriorating lung function and Pseudomonas aeruginosa infection as contributing to acute exacerbations, eliminating these factors does not entirely prevent such episodes in patients with bronchiectasis. Current research suggests that 20-40% of patients with bronchiectasis experience anxiety and/or depression. These conditions are associated with an increased risk of disease exacerbation, with depression specifically linked to a shorter time to first exacerbation. Therefore, investigating the intrinsic role of anxiety and depression in disease progression is crucial.
According to the inclusion and exclusion criteria, this study will enroll participants diagnosed with bronchiectasis at Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Guizhou Provincial People's Hospital, and Yichang Central Hospital between December 20, 2025, and December 31, 2030. The study protocol was approved by the research ethics boards at each hospital. At enrolment, the following demographic information will be collected: gender, age, height (in metres) and weight (in kilograms). Medical history, previous exacerbations and blood test results (including complete blood count and biochemical parameters) will also be obtained during the initial consultation. Pathogenic examination results will also be recorded. Additionally, pulmonary function tests (e.g. FEV1% predicted) and high-resolution computed tomography (HRCT) scans of the lungs will be performed. Patients' breathlessness will be assessed using the modified Medical Research Council (mMRC) dyspnoea scale, while anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS). With informed consent, biological samples, including blood, sputum and stool, were collected. Participants underwent follow-up every three months post-enrolment, with records maintained of exacerbation frequency, hospitalisation episodes and survival status. Upon completion of data collection, metabolomic analysis will be performed on samples including blood, sputum, and stool to investigate whether patients' anxiety and depression states are associated with the aforementioned metabolomic findings, identify corresponding biomarkers, and analyze the role of anxiety and depression in the progression of bronchiectasis.
Materials and Methods
- Data Collection Inclusion and exclusion criteria
Inclusion Criteria:
- Age ≥18 years
- Participants' pulmonary imaging findings and clinical presentation met the diagnostic criteria for bronchiectasis
- Clinically stable (no antibiotics or oral corticosteroids within 4 weeks prior to enrolment);
- Patients who are willing to sign the consent form and participate in the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Participants' pulmonary imaging findings and clinical presentation met the diagnostic criteria for bronchiectasis
- •Clinically stable (no antibiotics or oral corticosteroids within 4 weeks prior to enrolment);
- •Patients who are willing to sign the consent form and participate in the study.
排除标准
- •Age <18 years
- •Does not meet the diagnostic criteria for bronchiectasis
- •Participants with cystic fibrosis or previous lung transplantation
- •Participants who are unable to cooperate with the study due to dysfunction of vital systems such as heart, brain, liver, and kidneys, or who are unable to participate in the study due to comorbid serious diseases
- •Participants with active disorders, including active tuberculosis, active allergic bronchopulmonary aspergillosis, active nontuberculous mycobacterial infection and malignancy or secondary traction bronchiectasis associated with pulmonary fibrosis
- •Pregnant or lactating females
- •Who are not able to provide informed consent or who refuse to participate in the clinical study
结局指标
主要结局
Frequency of acute exacerbations of bronchiectasis
时间窗: up to 5 years
Acute exacerbations of bronchiectasis were defined according to the consensus published in the European Journal of Respiratory Sciences in 2017, and the frequency of acute exacerbations per year was obtained from participants through follow-up visits
次要结局
- Mortality rate(Five-year mortality rate)
- Hospital Anxiety and Depression Scale (HADS)(Lasts for 5 years)
- Lung Function FVC measured in liters (L)(recorded at baseline and re-tested every year, up to 5 years.)
- Lung Function FEV1%(recorded at baseline and re-tested every year, up to 5 years.)
- Lung Function - The FEV1/FVC ratio(recorded at baseline and re-tested every year, up to 5 years.)
- modified Medical Research Council (mMRC) dyspnea score(At baseline and updated once a year for 5 years)
- Bhalla scores on CT of participants' lungs(Assess once a year from the start of enrollment, for a total duration of five years.)
- Frequency of hospitalisation(Starting from inclusion in the study, data will be summarized once per year for a total duration of five years.)
- Bronchiectasis severity Score (BSI)(At baseline and updated once a year for 5 years)
- E-FACED score(At baseline and updated once a year for 5 years)
- Quality of Life Questionnaire-Bronchiectasis(At baseline and updated once a year for 5 years)
- Microbiology checklist(At least 1 year before enrollment and 5 years during the follow-up)
研究者
Wang xiaorong
Internal medicine physician
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology