NCT06344000

Brief Summary

Bronchiectasis is a common lung disease. The Bronchiectasis Severity Index (BSI) is a widely used assessment system. The body mass index (BMI) is a commonly used measure of nutritional status, but it has its limitations. To provide a more comprehensive assessment, the investigators also consider other nutrition-related indices such as upper arm circumference, calf circumference, skinfold thickness and grip strength. The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants' disease progression.

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
12mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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 Progress69%
Apr 2024Apr 2027

First Submitted

Initial submission to the registry

March 25, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

March 25, 2024

Last Update Submit

September 20, 2025

Conditions

Bronchiectasis

Keywords

NutritionBronchiectasis

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 (5)

  • 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.

  • Bhalla scores on CT of participants' lungs

    From the start of inclusion to one year later

  • Frequency of hospitalisation

    From the start of inclusion to one year later.

  • Death

    From the start of inclusion to one year later.

Interventions

inapplicableOTHER

inapplicable

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
  • Participants' pulmonary imaging findings and clinical presentation met the diagnostic criteria for bronchiectasis
  • Informed consent was signed

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
  • Pregnant or lactating females
  • Who are not able to provide informed consent or who refuse to participate in the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Wuhan Union Hospital,China

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (12)

  • Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats AJS, Crivelli AN, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee, GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):207-217. doi: 10.1002/jcsm.12383.

    PMID: 30920778BACKGROUND

  • Calanas-Continente A, Gutierrez-Botella J, Garcia-Curras J, Cobos MJ, Vaquero JM, Herrera A, Molina MJ, Galvez MA. Global Leadership Initiative on Malnutrition-Diagnosed Malnutrition in Lung Transplant Candidates. Nutrients. 2024 Jan 27;16(3):376. doi: 10.3390/nu16030376.

    PMID: 38337661BACKGROUND

  • Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.

    PMID: 24328736BACKGROUND

  • Despotes KA, Choate R, Addrizzo-Harris D, Aksamit TR, Barker A, Basavaraj A, Daley CL, Eden E, DiMango A, Fennelly K, Philley J, Johnson MM, McShane PJ, Metersky ML, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL, Knowles MR, Daniels MLA, Noone PG. Nutrition and Markers of Disease Severity in Patients With Bronchiectasis. Chronic Obstr Pulm Dis. 2020 Oct;7(4):390-403. doi: 10.15326/jcopdf.7.4.2020.0178.

    PMID: 33108111BACKGROUND

  • Onen ZP, Gulbay BE, Sen E, Yildiz OA, Saryal S, Acican T, Karabiyikoglu G. Analysis of the factors related to mortality in patients with bronchiectasis. Respir Med. 2007 Jul;101(7):1390-7. doi: 10.1016/j.rmed.2007.02.002. Epub 2007 Mar 19.

    PMID: 17374480BACKGROUND

  • Qi Q, Li T, Li JC, Li Y. Association of body mass index with disease severity and prognosis in patients with non-cystic fibrosis bronchiectasis. Braz J Med Biol Res. 2015 Aug;48(8):715-24. doi: 10.1590/1414-431X20154135. Epub 2015 Jul 10.

    PMID: 26176309BACKGROUND

  • Cao C, Wang R, Wang J, Bunjhoo H, Xu Y, Xiong W. Body mass index and mortality in chronic obstructive pulmonary disease: a meta-analysis. PLoS One. 2012;7(8):e43892. doi: 10.1371/journal.pone.0043892. Epub 2012 Aug 24.

    PMID: 22937118BACKGROUND

  • Kwan HY, Maddocks M, Nolan CM, Jones SE, Patel S, Barker RE, Kon SSC, Polkey MI, Cullinan P, Man WD. The prognostic significance of weight loss in chronic obstructive pulmonary disease-related cachexia: a prospective cohort study. J Cachexia Sarcopenia Muscle. 2019 Dec;10(6):1330-1338. doi: 10.1002/jcsm.12463. Epub 2019 Jun 17.

    PMID: 31207189BACKGROUND

  • Vestbo J, Prescott E, Almdal T, Dahl M, Nordestgaard BG, Andersen T, Sorensen TI, Lange P. Body mass, fat-free body mass, and prognosis in patients with chronic obstructive pulmonary disease from a random population sample: findings from the Copenhagen City Heart Study. Am J Respir Crit Care Med. 2006 Jan 1;173(1):79-83. doi: 10.1164/rccm.200506-969OC.

    PMID: 16368793BACKGROUND

  • Hachisu Y, Murata K, Takei K, Tsuchiya T, Tsurumaki H, Koga Y, Horie T, Takise A, Hisada T. Prognostic nutritional index as a predictor of mortality in nontuberculous mycobacterial lung disease. J Thorac Dis. 2020 Jun;12(6):3101-3109. doi: 10.21037/jtd-20-803.

    PMID: 32642232BACKGROUND

  • Miano N, Di Marco M, Alaimo S, Coppolino G, L'Episcopo G, Leggio S, Scicali R, Piro S, Purrello F, Di Pino A. Controlling Nutritional Status (CONUT) Score as a Potential Prognostic Indicator of In-Hospital Mortality, Sepsis and Length of Stay in an Internal Medicine Department. Nutrients. 2023 Mar 23;15(7):1554. doi: 10.3390/nu15071554.

    PMID: 37049392BACKGROUND

  • Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.

    PMID: 28596426BACKGROUND

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

18627195231rong-100@163.com

Jianping Song

CONTACT

15623201915songjianpingxh@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

March 25, 2024

First Posted

April 3, 2024

Study Start

April 15, 2024

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

September 25, 2025

Record last verified: 2025-09

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

CN(2)