Research on the Mechanism Affecting Progression of Bronchiectasis
NCT ID: NCT05731427
Last Updated: 2026-01-05
Study Results
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Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-02-01
2030-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pseudomonas aeruginosa colonization group
Colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Pseudomonas aeruginosa colonization infection
With or without airway Pseudomonas aeruginosa colonization infection
Non-Pseudomonas aeruginosa colonization group
No colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Pseudomonas aeruginosa colonization infection
With or without airway Pseudomonas aeruginosa colonization infection
Before treatment with macrolides
Before treatment with macrolides in patients with bronchiectasis
Macrolides
Before or after 6 months of treatment with macrolides for patients with bronchiectasis
After treatment with macrolides
After 6 months of treatment with macrolides for patients with bronchiectasis
Macrolides
Before or after 6 months of treatment with macrolides for patients with bronchiectasis
Interventions
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Pseudomonas aeruginosa colonization infection
With or without airway Pseudomonas aeruginosa colonization infection
Macrolides
Before or after 6 months of treatment with macrolides for patients with bronchiectasis
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Lack of important clinical information
18 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Wang xiaorong
Attending physician
Principal Investigators
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Xiaorong Wang
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Guizhou Provincial people's Hospital
Guiyang, Guizhou, China
Wuhan Union Hospital
Wuhan, Hubei, China
Department of Respiratory and Critical Care Medicine, Yichang Central People's Hospital
Yichang, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020XHHX002
Identifier Type: -
Identifier Source: org_study_id
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