Study on the Correlation Between Metabolomics and Anxiety and Depression in Bronchiectasis
NCT ID: NCT07291167
Last Updated: 2025-12-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
300 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-12-20
Study Completion Date
2030-12-31
Brief Summary
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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.
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.
Detailed Description
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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
1. 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.
Exclusion Criteria:
* 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
Collection of patient demographic indicators and laboratory test results. Demographic indicators (age, height, weight), mMRC score, laboratory test results, pulmonary function (FEV1% predicted), radiological scores (modified Reiff, Bhalla score) were collected upon participant enrolment.
Assessment of Anxiety and Depression Status：All patients were requested to complete the Hospital Anxiety and Depression Scale (HADS) at baseline. The score for each subscale (HADS depression and anxiety) ranges from 0 to 21 points, with a score ⩾8 indicating probable depression or anxiety .
Assessment of Disease Severity：Disease severity was evaluated using the Bronchiectasis Severity Index (BSI).
2. Metabolomics Experimental MethodsMetabolomics Experimental Methods 2.1 Sample Preparation 50 μL of collected sample was thawed on ice and mixed with 200 μL of cold methanol:acetonitrile (1:1, v/v) containing the IS (1 μg/mL). The mixture was vortexed vigorously, incubated at -20°C for 2 h, and then centrifuged at 14,000 g for 15 min at 4°C. The supernatant was transferred to a new vial for LC-MS analysis. A pooled quality control (QC) sample was prepared by combining equal aliquots from all individual samples.
2.2 LC-MS Analysis Chromatographic separation was performed on a Waters ACQUITY UPLC system using a HSS T3 column (2.1 × 100 mm, 1.8 μm) maintained at 40°C. The mobile phase consisted of (A) water with 0.1% formic acid and (B) acetonitrile with 0.1% formic acid. A linear gradient was applied as follows: 0-2 min, 2% B; 2-10 min, 2% to 98% B; 10-12 min, 98% B; 12-12.1 min, 98% to 2% B; 12.1-15 min, 2% B. The flow rate was 0.4 mL/min and the injection volume was 2 μL.
\> Mass spectrometry was conducted on a SCIEX TripleTOF 6600+ system operated in both positive and negative ESI modes. The parameters were set as follows: Ion Source Gas 1: 60 psi, Ion Source Gas 2: 60 psi, Curtain Gas: 35 psi, Source Temperature: 550°C, Ion Spray Voltage: ±5500 V. Data were acquired in information-dependent acquisition (IDA) mode.
2.3 Data Processing and Multivariate Statistical Analysis Raw data files were processed using MS-DIAL software for peak picking, alignment, and normalization against the IS. The resulting data matrix was imported into SIMCA-P software (v16.0, Umetrics, Sweden) for multivariate analysis. Unit variance scaling and mean centering were applied prior to PCA and OPLS-DA. The OPLS-DA model was validated by a 200-time permutation test.
Metabolites with Variable Importance in Projection (VIP) \> 1.0 from the OPLS-DA model and p-value \< 0.05 from univariate Student's t-test were considered statistically significant.
2.4 Metabolite Identification Significant metabolites were identified by comparing their accurate mass (mass error \< 10 ppm) and MS/MS spectra with entries in the HMDB database. Where possible, identification was confirmed by comparison with authentic standards (Level 1 confidence).
3. Clinical Data Statistical Analysis and Methods:
The data obtained during the study were pre-collated. For continuous data, normality tests were first performed. If all groups met normality, the Student's t-test was used for comparison between groups. Otherwise, the non-parametric Wilcoxon rank sum test was considered. For categorical variables, the χ2 test was used. Statistically significant data were subjected to multivariate logistic regression analysis. P \< 0.05 was deemed statistically significant.
Statistical analysis of all data was performed through SPSS (IBM SPSS Statistics 26.0, SPSS Inc., Chicago, IL) and R language (version 4.1.3, www.R-project.org/). All statistical tests were two-sided, and statistical significance was set at 0.05.
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
1. 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.
Exclusion Criteria:
* 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
Collection of patient demographic indicators and laboratory test results. Demographic indicators (age, height, weight), mMRC score, laboratory test results, pulmonary function (FEV1% predicted), radiological scores (modified Reiff, Bhalla score) were collected upon participant enrolment.
Assessment of Anxiety and Depression Status：All patients were requested to complete the Hospital Anxiety and Depression Scale (HADS) at baseline. The score for each subscale (HADS depression and anxiety) ranges from 0 to 21 points, with a score ⩾8 indicating probable depression or anxiety .
Assessment of Disease Severity：Disease severity was evaluated using the Bronchiectasis Severity Index (BSI).
2. Metabolomics Experimental MethodsMetabolomics Experimental Methods 2.1 Sample Preparation 50 μL of collected sample was thawed on ice and mixed with 200 μL of cold methanol:acetonitrile (1:1, v/v) containing the IS (1 μg/mL). The mixture was vortexed vigorously, incubated at -20°C for 2 h, and then centrifuged at 14,000 g for 15 min at 4°C. The supernatant was transferred to a new vial for LC-MS analysis. A pooled quality control (QC) sample was prepared by combining equal aliquots from all individual samples.
2.2 LC-MS Analysis Chromatographic separation was performed on a Waters ACQUITY UPLC system using a HSS T3 column (2.1 × 100 mm, 1.8 μm) maintained at 40°C. The mobile phase consisted of (A) water with 0.1% formic acid and (B) acetonitrile with 0.1% formic acid. A linear gradient was applied as follows: 0-2 min, 2% B; 2-10 min, 2% to 98% B; 10-12 min, 98% B; 12-12.1 min, 98% to 2% B; 12.1-15 min, 2% B. The flow rate was 0.4 mL/min and the injection volume was 2 μL.
\> Mass spectrometry was conducted on a SCIEX TripleTOF 6600+ system operated in both positive and negative ESI modes. The parameters were set as follows: Ion Source Gas 1: 60 psi, Ion Source Gas 2: 60 psi, Curtain Gas: 35 psi, Source Temperature: 550°C, Ion Spray Voltage: ±5500 V. Data were acquired in information-dependent acquisition (IDA) mode.
2.3 Data Processing and Multivariate Statistical Analysis Raw data files were processed using MS-DIAL software for peak picking, alignment, and normalization against the IS. The resulting data matrix was imported into SIMCA-P software (v16.0, Umetrics, Sweden) for multivariate analysis. Unit variance scaling and mean centering were applied prior to PCA and OPLS-DA. The OPLS-DA model was validated by a 200-time permutation test.
Metabolites with Variable Importance in Projection (VIP) \> 1.0 from the OPLS-DA model and p-value \< 0.05 from univariate Student's t-test were considered statistically significant.
2.4 Metabolite Identification Significant metabolites were identified by comparing their accurate mass (mass error \< 10 ppm) and MS/MS spectra with entries in the HMDB database. Where possible, identification was confirmed by comparison with authentic standards (Level 1 confidence).
3. Clinical Data Statistical Analysis and Methods:
The data obtained during the study were pre-collated. For continuous data, normality tests were first performed. If all groups met normality, the Student's t-test was used for comparison between groups. Otherwise, the non-parametric Wilcoxon rank sum test was considered. For categorical variables, the χ2 test was used. Statistically significant data were subjected to multivariate logistic regression analysis. P \< 0.05 was deemed statistically significant.
Statistical analysis of all data was performed through SPSS (IBM SPSS Statistics 26.0, SPSS Inc., Chicago, IL) and R language (version 4.1.3, www.R-project.org/). All statistical tests were two-sided, and statistical significance was set at 0.05.
Conditions
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Bronchiectasis
Keywords
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Bronchiectasis
Depression
Anxiety
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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inapplicable
This study is observational in nature and did not involve any intervention measures.
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Sponsor Role
lead
Responsible Party
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Wang xiaorong
Internal medicine physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Wuhan Union Hospital,China
Wuhan, Hubei, China
Site Status
Countries
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China
Central Contacts
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Facility Contacts
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Xiaorong Wang
Role: primary
Jianping Song
Role: backup
References
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Lee JH, Lee WY, Yong SJ, Kim WJ, Sin S, Lee CY, Kim Y, Jung JY, Kim SH; KMBARC. Prevalence of depression and its associated factors in bronchiectasis: findings from KMBARC registry. BMC Pulm Med. 2021 Sep 27;21(1):306. doi: 10.1186/s12890-021-01675-4.
Reference Type
RESULT
Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
Reference Type
RESULT
Hill AT, Sullivan AL, Chalmers JD, De Soyza A, Elborn SJ, Floto AR, Grillo L, Gruffydd-Jones K, Harvey A, Haworth CS, Hiscocks E, Hurst JR, Johnson C, Kelleher PW, Bedi P, Payne K, Saleh H, Screaton NJ, Smith M, Tunney M, Whitters D, Wilson R, Loebinger MR. British Thoracic Society Guideline for bronchiectasis in adults. Thorax. 2019 Jan;74(Suppl 1):1-69. doi: 10.1136/thoraxjnl-2018-212463. No abstract available.
Reference Type
RESULT
Gao YH, Guan WJ, Zhu YN, Chen RC, Zhang GJ. Anxiety and depression in adult outpatients with bronchiectasis: Associations with disease severity and health-related quality of life. Clin Respir J. 2018 Apr;12(4):1485-1494. doi: 10.1111/crj.12695. Epub 2017 Sep 19.
Reference Type
RESULT
Gao YH, Zheng HZ, Lu HW, Li YY, Feng Y, Mao B, Bai JW, Liang S, Cheng KB, Gu SY, Sun XL, Li JX, Ge A, Li MH, Yang JW, Bai L, Yu HY, Qu JM, Xu JF. The impact of depression and anxiety on the risk of exacerbation in adults with bronchiectasis: a prospective cohort study. Eur Respir J. 2023 Feb 2;61(2):2201695. doi: 10.1183/13993003.01695-2022. Print 2023 Feb. No abstract available.
Reference Type
RESULT
Other Identifiers
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2025XHHX001
Identifier Type: -
Identifier Source: org_study_id