NCT06346938

Brief Summary

As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

March 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2027

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

March 26, 2024

Last Update Submit

August 13, 2025

Conditions

Keywords

BronchiectasisComputed Tomographybiomarkers

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.

    From the start of inclusion to one year later.

Secondary Outcomes (7)

  • Deterioration of lung function

    From the start of inclusion to one year later.

  • Severity of dyspnoea

    From the start of inclusion to one year later.

  • Degree of emphysema

    From the start of inclusion to one year later.

  • Mucus plug score

    From the start of inclusion to one year later.

  • Bhalla scores on CT of participants' lungs

    From the start of inclusion to one year later.

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with lung Computed Tomography findings and clinical symptoms consistent with bronchiectasis.

You may qualify if:

  • Age 18 years and above;
  • Can cooperate with CT scan;
  • Bronchiectasis confirmed by high-resolution computed tomography of the lungs;
  • Can provide written informed consent

You may not qualify if:

  • Pulmonary surgery;
  • Patients with lung cancer, asthma and other respiratory diseases;
  • Tractive bronchiectasis caused by pulmonary fibrosis;
  • Patients with malignant tumors or serious dysfunction of the heart, brain, kidney and other important systems can not cooperate with the completion of this study;
  • Lack of important clinical information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (16)

  • Weycker D, Hansen GL, Seifer FD. Prevalence and incidence of noncystic fibrosis bronchiectasis among US adults in 2013. Chron Respir Dis. 2017 Nov;14(4):377-384. doi: 10.1177/1479972317709649. Epub 2017 May 30.

    PMID: 28555504BACKGROUND
  • Quint JK, Millett ER, Joshi M, Navaratnam V, Thomas SL, Hurst JR, Smeeth L, Brown JS. Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004 to 2013: a population-based cohort study. Eur Respir J. 2016 Jan;47(1):186-93. doi: 10.1183/13993003.01033-2015. Epub 2015 Nov 5.

    PMID: 26541539BACKGROUND
  • Monteagudo M, Rodriguez-Blanco T, Barrecheguren M, Simonet P, Miravitlles M. Prevalence and incidence of bronchiectasis in Catalonia, Spain: A population-based study. Respir Med. 2016 Dec;121:26-31. doi: 10.1016/j.rmed.2016.10.014. Epub 2016 Oct 25.

    PMID: 27888988BACKGROUND
  • Tiddens HAWM, Meerburg JJ, van der Eerden MM, Ciet P. The radiological diagnosis of bronchiectasis: what's in a name? Eur Respir Rev. 2020 Jun 17;29(156):190120. doi: 10.1183/16000617.0120-2019. Print 2020 Jun 30.

    PMID: 32554759BACKGROUND
  • Bonavita J, Naidich DP. Imaging of bronchiectasis. Clin Chest Med. 2012 Jun;33(2):233-48. doi: 10.1016/j.ccm.2012.02.007.

    PMID: 22640843BACKGROUND
  • Aliberti S, Goeminne PC, O'Donnell AE, Aksamit TR, Al-Jahdali H, Barker AF, Blasi F, Boersma WG, Crichton ML, De Soyza A, Dimakou KE, Elborn SJ, Feldman C, Tiddens H, Haworth CS, Hill AT, Loebinger MR, Martinez-Garcia MA, Meerburg JJ, Menendez R, Morgan LC, Murris MS, Polverino E, Ringshausen FC, Shteinberg M, Sverzellati N, Tino G, Torres A, Vandendriessche T, Vendrell M, Welte T, Wilson R, Wong CA, Chalmers JD. Criteria and definitions for the radiological and clinical diagnosis of bronchiectasis in adults for use in clinical trials: international consensus recommendations. Lancet Respir Med. 2022 Mar;10(3):298-306. doi: 10.1016/S2213-2600(21)00277-0. Epub 2021 Sep 24.

    PMID: 34570994BACKGROUND
  • Wu FJ, Qi Q, Hu Q, Xu LS. [Correlation between chest CT features and clinical characteristics of patients with bronchiectasis]. Zhonghua Yi Xue Za Zhi. 2019 Oct 15;99(38):2982-2988. doi: 10.3760/cma.j.issn.0376-2491.2019.38.004. Chinese.

    PMID: 31607029BACKGROUND
  • Chassagnon G, Brun AL, Bennani S, Chergui N, Freche G, Revel MP. [Bronchiectasis imaging]. Rev Pneumol Clin. 2018 Oct;74(5):299-314. doi: 10.1016/j.pneumo.2018.09.009. Epub 2018 Oct 19. French.

    PMID: 30348546BACKGROUND
  • Flume PA, Chalmers JD, Olivier KN. Advances in bronchiectasis: endotyping, genetics, microbiome, and disease heterogeneity. Lancet. 2018 Sep 8;392(10150):880-890. doi: 10.1016/S0140-6736(18)31767-7.

    PMID: 30215383BACKGROUND
  • Gao L, Qin KR, Li T, Wang HL, Pang M. The clinical phenotype of bronchiectasis and its clinical guiding implications. Exp Biol Med (Maywood). 2021 Feb;246(3):275-280. doi: 10.1177/1535370220972324. Epub 2020 Nov 26.

    PMID: 33241711BACKGROUND
  • Martinez-Garcia MA, Olveira C, Maiz L, Giron RM feminine, Prados C, de la Rosa D, Blanco M, Agusti A. Bronchiectasis: A Complex, Heterogeneous Disease. Arch Bronconeumol (Engl Ed). 2019 Aug;55(8):427-433. doi: 10.1016/j.arbres.2019.02.024. Epub 2019 Apr 18. English, Spanish.

    PMID: 31005356BACKGROUND
  • Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.

    PMID: 20627931BACKGROUND
  • Dicker AJ, Lonergan M, Keir HR, Smith AH, Pollock J, Finch S, Cassidy AJ, Huang JTJ, Chalmers JD. The sputum microbiome and clinical outcomes in patients with bronchiectasis: a prospective observational study. Lancet Respir Med. 2021 Aug;9(8):885-896. doi: 10.1016/S2213-2600(20)30557-9. Epub 2021 May 4.

    PMID: 33961805BACKGROUND
  • Martinez-Garcia MA, Miravitlles M. Bronchiectasis in COPD patients: more than a comorbidity? Int J Chron Obstruct Pulmon Dis. 2017 May 11;12:1401-1411. doi: 10.2147/COPD.S132961. eCollection 2017.

    PMID: 28546748BACKGROUND
  • Poppelwell L, Chalmers JD. Defining severity in non-cystic fibrosis bronchiectasis. Expert Rev Respir Med. 2014 Apr;8(2):249-62. doi: 10.1586/17476348.2014.896204.

    PMID: 24601664BACKGROUND
  • Tang X, Bi J, Yang D, Chen S, Li Z, Chen C, Wang G, Ju M, Wang J, Wang Y, Gong R, Bai C, Zhuo H, Jin X, Song Y. Emphysema is an independent risk factor for 5-year mortality in patients with bronchiectasis. Clin Respir J. 2017 Nov;11(6):887-894. doi: 10.1111/crj.12432. Epub 2016 Jan 11.

    PMID: 26662880BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • xiaorong Wang

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaorong Wang

CONTACT

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

March 26, 2024

First Posted

April 4, 2024

Study Start

March 30, 2024

Primary Completion (Estimated)

March 26, 2027

Study Completion (Estimated)

March 26, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

In this study, we will share parts of the study design such as Study Protocol, Statistical Analysis Plan (SAP) and Informed Consent Form (ICF).

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