Study on the Correlation Between Metabolomics and Anxiety and Depression in Bronchiectasis

NCT07291167 | Not Yet Recruiting DMC

• 1 other identifier: 2025XHHX001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Frequency of acute exacerbations of bronchiectasis

  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

  up to 5 years

Secondary Outcomes (12)

• 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

Interventions

inapplicable OTHER

This study is observational in nature and did not involve any intervention measures.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with all-cause bronchiectasis would be included, such as those with tuberculosis history and genetic disorders.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital,China

Wuhan, Hubei, 430030, China

Location

Related Publications (5)

• 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.

  PMID: 28889110 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.

  PMID: 30545985 RESULT

• 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.

  PMID: 34579692 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.

  PMID: 28842946 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.

  PMID: 36669778 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, sputum, stool would be collected and stored at - 80℃

MeSH Terms

Conditions

Bronchiectasis; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Xiaorong Wang

CONTACT

+86 18627195231; rong-100@163.com

Jianping Song

CONTACT

+86 15623201915; songjianpingxh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine physician

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: December 18, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will share the data 6 months after the end of the study, which lasts for 3 years
• Access Criteria: Data were obtained through the Principal Investigator of this study upon reasonable request.

Locations

CN (1)