NCT01761214

Brief Summary

Bronchiectasis is a chronic disease arises from progressive airway inflammation and infection. It has been postulated that bacterial infection triggers intense airway inflammation leading to acute exacerbation of bronchiectasis. Antibiotics have been the most potent medications for the treatment of bronchiectasis, however, the sputum bacterial load and inflammatory indices at steady-state and exacerbation remain largely unknown. The investigation might shed light on the roles that antibiotics play in acute exacerbation of bronchiectasis and uncover the mechanisms on why a subgroup of individuals do not respond satisfactorily.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

11.3 years

First QC Date

January 3, 2013

Last Update Submit

February 8, 2020

Conditions

Bronchiectasis

Keywords

bacteriology, inflammation, bronchiectasis, exacerbation

Outcome Measures

Primary Outcomes (1)

  • Sputum microbiology

    type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter

    1 year

Secondary Outcomes (8)

  • Sputum sol phase inflammatory indices

    1 year

  • 24-hour sputum volume

    1 year

  • Spirometry

    1 year

  • Sputum purulence

    1 year

  • Sputum viscosity

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Fluroquinolones

ACTIVE COMPARATOR

The fluroquinolones employed in the present study are referred to as oral levofloxacin (500mg q.d.), moxifloxacin (400mg, q.d.) and ciprofloxacin (500mg, b.i.d.). All medications are administered based on the bronchiectasis guideline issued by British Thoracic Society.

Drug: Fluroquinolones

Beta-lactamase inhibitor

ACTIVE COMPARATOR

In the present study, amoxicillin and amoxicillin clavulanate potassium compound are employed, based on the British Thoracic Society guideline for bronchietasis, as mainly determined by sputum microbiology during steady-state bronchiectasis.

Drug: Beta-lactamase inhibitor

Interventions

FluroquinolonesDRUG

All antibiotics are administered based on British Thoracic Society guideline for bronchiectasis

Also known as: levoflocaxin (Cravit), moxifloxacin (Avelox), ciprofloxacin (Cifran)
Fluroquinolones
Beta-lactamase inhibitorDRUG

All antibiotics are administered based on British Thoracic Society guideline for bronchiectasis.

Also known as: amoxicillin clavulanate potassium compound (Junerqing)
Beta-lactamase inhibitor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of either sex and age between 18 and 70 years

You may not qualify if:

  • Patient judged to have poor compliance
  • Female patient who is lactating or pregnant
  • Patients having concomitant severe systemic illnesses (i.e. coronary heart disease, cerebral stroke, uncontrolled hypertension, active gastric ulcer, malignant tumor, hepatic dysfunction, renal dysfunction)
  • Miscellaneous conditions that would potentially influence efficacy assessment, as judged by the investigators
  • Participation in another clinical trial within the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (16)

  • Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.

    PMID: 11986413BACKGROUND

  • Fuschillo S, De Felice A, Balzano G. Mucosal inflammation in idiopathic bronchiectasis: cellular and molecular mechanisms. Eur Respir J. 2008 Feb;31(2):396-406. doi: 10.1183/09031936.00069007.

    PMID: 18238949BACKGROUND

  • Murray MP, Turnbull K, Macquarrie S, Hill AT. Assessing response to treatment of exacerbations of bronchiectasis in adults. Eur Respir J. 2009 Feb;33(2):312-8. doi: 10.1183/09031936.00122508. Epub 2008 Oct 1.

    PMID: 18829674BACKGROUND

  • Tsang KW, Tan KC, Ho PL, Ooi GC, Ho JC, Mak J, Tipoe GL, Ko C, Yan C, Lam WK, Chan-Yeung M. Inhaled fluticasone in bronchiectasis: a 12 month study. Thorax. 2005 Mar;60(3):239-43. doi: 10.1136/thx.2002.003236.

    PMID: 15741443BACKGROUND

  • 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

  • Tsang KW, Ho PL, Lam WK, Ip MS, Chan KN, Ho CS, Ooi CC, Yuen KY. Inhaled fluticasone reduces sputum inflammatory indices in severe bronchiectasis. Am J Respir Crit Care Med. 1998 Sep;158(3):723-7. doi: 10.1164/ajrccm.158.3.9710090.

    PMID: 9730996BACKGROUND

  • Tsang KW, Chan K, Ho P, Zheng L, Ooi GC, Ho JC, Lam W. Sputum elastase in steady-state bronchiectasis. Chest. 2000 Feb;117(2):420-6. doi: 10.1378/chest.117.2.420.

    PMID: 10669685BACKGROUND

  • Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. doi: 10.1136/thx.2006.061648.

    PMID: 16936234BACKGROUND

  • Zheng J, Zhong N. Normative values of pulmonary function testing in Chinese adults. Chin Med J (Engl). 2002 Jan;115(1):50-4.

    PMID: 11930658BACKGROUND

  • Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.

    PMID: 22744718RESULT

  • Kapur N, Masters IB, Chang AB. Exacerbations in noncystic fibrosis bronchiectasis: Clinical features and investigations. Respir Med. 2009 Nov;103(11):1681-7. doi: 10.1016/j.rmed.2009.05.007. Epub 2009 Jun 6.

    PMID: 19501498RESULT

  • Guan WJ, Yuan JJ, Gao YH, Li HM, Zheng JP, Chen RC, Zhong NS. Maximal mid-expiratory flow is a surrogate marker of lung clearance index for assessment of adults with bronchiectasis. Sci Rep. 2016 Jun 24;6:28467. doi: 10.1038/srep28467.

    PMID: 27339787DERIVED

  • Guan WJ, Gao YH, Xu G, Li HM, Yuan JJ, Zheng JP, Chen RC, Zhong NS. Bronchodilator response in adults with bronchiectasis: correlation with clinical parameters and prognostic implications. J Thorac Dis. 2016 Jan;8(1):14-23. doi: 10.3978/j.issn.2072-1439.2016.01.05.

    PMID: 26904207DERIVED

  • Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Jiang M, Zheng JP, Chen RC, Zhong NS. Inflammatory Responses, Spirometry, and Quality of Life in Subjects With Bronchiectasis Exacerbations. Respir Care. 2015 Aug;60(8):1180-9. doi: 10.4187/respcare.04004. Epub 2015 Jun 9.

    PMID: 26060319DERIVED

  • Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Impulse oscillometry in adults with bronchiectasis. Ann Am Thorac Soc. 2015 May;12(5):657-65. doi: 10.1513/AnnalsATS.201406-280OC.

    PMID: 25654540DERIVED

  • Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Characterization of lung function impairment in adults with bronchiectasis. PLoS One. 2014 Nov 18;9(11):e113373. doi: 10.1371/journal.pone.0113373. eCollection 2014.

    PMID: 25405614DERIVED

MeSH Terms

Conditions

BronchiectasisInflammation

Interventions

MoxifloxacinCiprofloxacincifranbeta-Lactamase Inhibitors

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnti-Bacterial AgentsAnti-Infective AgentsTherapeutic Uses

Study Officials

  • Nan-shan Zhong, M. D.

    Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

    PRINCIPAL INVESTIGATOR

  • Rong-chang Chen, M. D.

    Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 4, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)