Research on the Mechanism Affecting Progression of Bronchiectasis

NCT05731427 | Recruiting

• 1 other identifier: 2020XHHX002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Microbiota; Pseudomonas aeruginosa

Outcome Measures

Primary Outcomes (1)

• Acute exacerbations and mortality

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

  February 10, 2026

Secondary Outcomes (3)

• Lung function

  February 10, 2026

• Symptoms assessment

  February 10, 2026

• Stool and sputum microtioba

  February 10, 2026

Study Arms (4)

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

Pseudomonas aeruginosa colonization infection DIAGNOSTIC_TEST

With or without airway Pseudomonas aeruginosa colonization infection

Non-Pseudomonas aeruginosa colonization group; Pseudomonas aeruginosa colonization group

Macrolides DRUG

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

After treatment with macrolides; Before treatment with macrolides

Eligibility Criteria

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

Study Population

All patients with bronchiectasis was recruited from Wuhan Union Hospital.

You may qualify if:

• 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 informed consent

You may not qualify if:

• Traction bronchiectasis
• Lack of important clinical information

Sponsors & Collaborators

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

Study Sites (3)

Guizhou Provincial people's Hospital

Guiyang, Guizhou, 550002, China

RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Department of Respiratory and Critical Care Medicine, Yichang Central People's Hospital

Yichang, Hubei, 443000, China

RECRUITING

Related Publications (13)

• 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.

  PMID: 29371383 BACKGROUND

• 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.

  PMID: 29371384 BACKGROUND

• 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.

  PMID: 29386336 BACKGROUND

• 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.

  PMID: 29540404 BACKGROUND

• 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: 31005356 BACKGROUND

• 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.

  PMID: 31364220 BACKGROUND

• 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.

  PMID: 31046405 BACKGROUND

• 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.

  PMID: 23532242 BACKGROUND

• 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.

  PMID: 31027086 BACKGROUND

• 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.

  PMID: 22288725 BACKGROUND

• 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.

  PMID: 22901887 BACKGROUND

• 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.

  PMID: 30687502 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis; Pseudomonas Infections

Interventions

Macrolides

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Xiaorong Wang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaorong Wang

CONTACT

18627195231; rong-100@163.com

Yaya Zhou

CONTACT

15972916036; 749833758@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: February 16, 2023
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

CN (3)