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RecruitingNCT05731427Updated Jan 5, 2026

Research on the Mechanism Affecting Progression of Bronchiectasis

An observational study in Bronchiectasis, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 84 studies in Bronchiectasis with a site in China — 35 open to participants now, 38 under way, 4 of them phase 3. Bronchiectasis · China.

Planned enrollment
30th of 34
150 · median 300
Started
2021
with 5 others
Observational
34 of 84
16 open now
Primary completion
2030-12
later than 36 of 37 live
Registered
37th of 84
by date
Lead sponsor
4 of 84
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Among the 84 studies in Bronchiectasis with a site in China, this one is the 30th largest by planned enrollment of the 34 observational ones that give a count, is one of 6 that started in 2021, is one of 34 observational ones, reaches primary completion later than 36 of the 37 other live ones, and was the 37th registered.

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

Browse Bronchiectasis studies →

Open to participants now

35 of the 84 studies in Bronchiectasis with a site in China are open now. Recruiting first, the newest first:

30 more — sign in →

All 35 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 93 Bronchiectasis studies recruiting now, 50 (54%) set no upper age limit and 13 (14%) stop at 75 or younger; 12 take children under 18; 26 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 84 studies in Bronchiectasis with a site in China, or all of them as a file.
02

Study summary

Bronchiectasis is a chronic inflammatory respiratory disease defined as the irreversible dilatation of one or more bronchi and is associated with chronic and frequently purulent expectoration, multiple exacerbations and progressive dyspnea. Bronchiectasis has a large heterogeneity. Different patients with bronchiectasis may have different etiology, clinical manifestations, and imaging features. Previous studies showed that there are significant relationship between the airway microbiome and the severity of the disease. For example, patient with airway Pseudomonas aeruginosa colonization has heavier symptoms, heavier severity, poorer quality of life, more acute exacerbations, and worse prognosis. A large number of studies have reported that long-term treatment of low-dose macrolides such as azithromycin or clarithromycin has anti-inflammatory and immunomodulatory effects, which can improve the clinical symptoms and disease progression of various chronic airway diseases, such as diffuse panbronchiolitis, chronic obstructive pulmonary disease, bronchiectasis. Both the 2017 European Respiratory Society guidelines and the 2019 British Thoracic Society Guideline recommend macrolide drugs for the treatment of chronic Pseudomonas aeruginosa colonization bronchiectasis or frequent acute exacerbations bronchiectasis, but the specific mechanism is unknown.This study is based on omics methods (Microbiology and Metabolomics) to deeply explore the composition of airway and gut microbiota in patients with bronchiectasis, the factors affecting the colonization of Pseudomonas aeruginosa and the mechanism of macrolides in the treatment of bronchiectasis.

This project is a multicenter clinical study involving patients with bronchiectasis from Wuhan Union Hospital, Guizhou Provincial People's Hospital, and Yichang Central People's Hospital. Patients with bronchiectasis were recruited according to the inclusion and exclusion criteria. Clinical data were collected from these patients (including demographic information, clinical characteristics, pulmonary function, and lung imaging), along with spontaneously expectorated sputum, feces, and peripheral blood, and the patients were followed for 24 months. The microbiome, metabolome, and cytokines in sputum and feces were assessed, as well as cytokines, inflammatory mediators, and metabolites in peripheral blood.

Through the above methods,investigators further understand the mechanism affecting progression of bronchiectasis and some factors that lead to the colonization of Pseudomonas aeruginosa, as well as mechanisms of macrolides in the treatment of bronchiectasis.

Read the detailed description

Clinical information:

Demographic information,blood test results,lung function,severity of disease was evaluated using the E-FACED and the Bronchiectasis Severity Index (BSI).The severity of dyspnea was assessed using the Medical Research Council (MRC) grade, and lung radiological severity was assessed using the modified Reiff score and Bhalla score.

Sputum collection:

We collect sputum samples from patients with bronchiectasis. We divided into two parts from each sputum sample, one part was immediately stored -80℃ for microbiota sequencing. The other part was diluted with PBS and centrifuged at 12000g for 5 minutes, and the supernatant was stored at -80°C for measurement of inflammatory factors, oxidative stress and other markers.

Stool collection:

We collect stool samples from patients with bronchiectasis.Fresh stools were processed in the laboratory within 30 min after collection and stored at -80°C until analysis.

Peripheral blood collection:

We collect peripheral blood samples from patients with bronchiectasis to detect inflammatory mediators and so on.

03

Conditions studied

  • Bronchiectasis

Keywords

  • Bronchiectasis
  • Microbiota
  • Pseudomonas aeruginosa
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with bronchiectasis was recruited from Wuhan Union Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years or older
  • Bronchiectasis confirmed by high-resolution computed tomographic scan(HRCT)
  • Chronic expectoration with ability to provide a sputum sample at the study visit
  • Provision of written

Exclusion criteria

Exclusion criteria:

  • Traction bronchiectasis
  • Lack of important clinical information
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pseudomonas aeruginosa colonization group

    Colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis

    Diagnostic Test: Pseudomonas aeruginosa colonization infection

  • Non-Pseudomonas aeruginosa colonization group

    No colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis

    Diagnostic Test: Pseudomonas aeruginosa colonization infection

  • Before treatment with macrolides

    Before treatment with macrolides in patients with bronchiectasis

    Drug: Macrolides

  • After treatment with macrolides

    After 6 months of treatment with macrolides for patients with bronchiectasis

    Drug: Macrolides

Interventions

  • Diagnostic testPseudomonas aeruginosa colonization infection

    With or without airway Pseudomonas aeruginosa colonization infection

  • Before or after 6 months of treatment with macrolides for patients with bronchiectasis

06

What researchers measure

Primary outcomes

  1. Acute exacerbations and mortality

    The number of acute exacerbations and outcome (death or survival) of patients with bronchiectasis after one year.

    Time frame: February 10, 2026

Secondary outcomes

  1. Lung function

    Forced expiratory volume in 1s (FEV1),Forced vital capacity(FVC)

    Time frame: February 10, 2026

  2. Symptoms assessment

    MRC score,cough score,sputum purulent score,sputum volume score and hemoptysis score

    Time frame: February 10, 2026

  3. Stool and sputum microtioba

    Stool and sputum microtioba from patients with bronchiectasis after one year

    Time frame: February 10, 2026

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan. PubMed 29371383 ↗
  • Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan. PubMed 29371384 ↗
  • Araujo D, Shteinberg M, Aliberti S, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Stone G, Trautmann M, Davis A, Dimakou K, Polverino E, De Soyza A, McDonnell MJ, Chalmers JD. The independent contribution of Pseudomonas aeruginosa infection to long-term clinical outcomes in bronchiectasis. Eur Respir J. 2018 Jan 31;51(2):1701953. doi: 10.1183/13993003.01953-2017. Print 2018 Feb. PubMed 29386336 ↗
  • Wang H, Ji XB, Mao B, Li CW, Lu HW, Xu JF. Pseudomonas aeruginosa isolation in patients with non-cystic fibrosis bronchiectasis: a retrospective study. BMJ Open. 2018 Mar 14;8(3):e014613. doi: 10.1136/bmjopen-2016-014613. PubMed 29540404 ↗
  • 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. PubMed 31005356 ↗
  • O'Neill K, Einarsson GG, Rowan S, McIlreavey L, Lee AJ, Lawson J, Lynch T, Horsley A, Bradley JM, Elborn JS, Tunney MM. Composition of airway bacterial community correlates with chest HRCT in adults with bronchiectasis. Respirology. 2020 Jan;25(1):64-70. doi: 10.1111/resp.13653. Epub 2019 Jul 30. PubMed 31364220 ↗
  • Vermeersch K, Gabrovska M, Aumann J, Demedts IK, Corhay JL, Marchand E, Slabbynck H, Haenebalcke C, Haerens M, Hanon S, Jordens P, Peche R, Fremault A, Lauwerier T, Delporte A, Vandenberk B, Willems R, Everaerts S, Belmans A, Bogaerts K, Verleden GM, Troosters T, Ninane V, Brusselle GG, Janssens W. Azithromycin during Acute Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization (BACE). A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care Med. 2019 Oct 1;200(7):857-868. doi: 10.1164/rccm.201901-0094OC. PubMed 31046405 ↗
  • Serisier DJ, Martin ML, McGuckin MA, Lourie R, Chen AC, Brain B, Biga S, Schlebusch S, Dash P, Bowler SD. Effect of long-term, low-dose erythromycin on pulmonary exacerbations among patients with non-cystic fibrosis bronchiectasis: the BLESS randomized controlled trial. JAMA. 2013 Mar 27;309(12):1260-7. doi: 10.1001/jama.2013.2290. PubMed 23532242 ↗
  • Wang D, Fu W, Dai J. Meta-analysis of macrolide maintenance therapy for prevention of disease exacerbations in patients with noncystic fibrosis bronchiectasis. Medicine (Baltimore). 2019 Apr;98(17):e15285. doi: 10.1097/MD.0000000000015285. PubMed 31027086 ↗
  • Hodge S, Reynolds PN. Low-dose azithromycin improves phagocytosis of bacteria by both alveolar and monocyte-derived macrophages in chronic obstructive pulmonary disease subjects. Respirology. 2012 Jul;17(5):802-7. doi: 10.1111/j.1440-1843.2012.02135.x. PubMed 22288725 ↗
  • Wong C, Jayaram L, Karalus N, Eaton T, Tong C, Hockey H, Milne D, Fergusson W, Tuffery C, Sexton P, Storey L, Ashton T. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):660-7. doi: 10.1016/S0140-6736(12)60953-2. PubMed 22901887 ↗
  • Hill AT, Sullivan AL, Chalmers JD, De Soyza A, Elborn JS, Floto RA, Grillo L, Gruffydd-Jones K, Harvey A, Haworth CS, Hiscocks E, Hurst JR, Johnson C, Kelleher WP, 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. BMJ Open Respir Res. 2018 Dec 28;5(1):e000348. doi: 10.1136/bmjresp-2018-000348. eCollection 2018. PubMed 30687502 ↗
  • 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. PubMed 28889110 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2021 (actual). Primary completion is estimated for Dec 2030, 118 months after the start.

Of 62 observational studies under Bronchiectasis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12. This study's planned 118 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2021
First posted
Feb 16, 2023
StartActual
Feb 1, 2021
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2030
Last update
Jan 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05731427
Responsible party
Wang xiaorong (Attending physician, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Feb 16, 2023
Start date
Feb 1, 2021
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jan 5, 2026

Study contacts

Xiaorong Wang
Contact
rong-100@163.com
18627195231 ext. +86
Yaya Zhou
Contact
749833758@qq.com
15972916036 ext. +86
Xiaorong Wang
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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