NCT01761214: BISER

Bacteriology and Sputum and Systemic Inflammation in Steady-state, Acute Exacerbation and Recovery of Bronchiectasis

Status unknown NA Last updated 8 February 2020

What this trial tests

NA trial testing Fluroquinolones in Bronchiectasis in 80 participants. Status unknown.

Timeline

1 September 2012

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	Guangzhou Institute of Respiratory Disease
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 September 2012
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	1 location across China

Drugs / interventions tested

• Fluroquinolones — full drug profile →
• Beta-lactamase inhibitor — full drug profile →

Conditions studied

• Bronchiectasis — all drugs for Bronchiectasis →

Sponsor

Guangzhou Institute of Respiratory Disease

Who can join

Adults 18 to 70, any sex, with Bronchiectasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Sputum microbiology
  Time frame: 1 year
  type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characterization of lung function impairment in adults with bronchiectasis.
   Guan WJ, Gao YH, Xu G, Lin ZY, et al · · 2014 · cited 42× · PMID 25405614 · DOI 10.1371/journal.pone.0113373
2. Impulse oscillometry in adults with bronchiectasis.
   Guan WJ, Gao YH, Xu G, Lin ZY, et al · · 2015 · cited 34× · PMID 25654540 · DOI 10.1513/annalsats.201406-280oc
3. Inflammatory Responses, Spirometry, and Quality of Life in Subjects With Bronchiectasis Exacerbations.
   Guan WJ, Gao YH, Xu G, Lin ZY, et al · · 2015 · cited 29× · PMID 26060319 · DOI 10.4187/respcare.04004
4. Bronchodilator response in adults with bronchiectasis: correlation with clinical parameters and prognostic implications.
   Guan WJ, Gao YH, Xu G, Li HM, et al · · 2016 · cited 21× · PMID 26904207 · DOI 10.3978/j.issn.2072-1439.2016.01.05
5. Altered community compositions of <i>Proteobacteria</i> in adults with bronchiectasis.
   Guan WJ, Yuan JJ, Li HM, Gao YH, et al · · 2018 · cited 9× · PMID 30140149 · DOI 10.2147/copd.s159335
6. Continuous versus intermittent antibiotics for bronchiectasis.
   Donovan T, Felix LM, Chalmers JD, Milan SJ, et al · · 2018 · cited 8× · PMID 29860722 · DOI 10.1002/14651858.cd012733.pub2
7. Maximal mid-expiratory flow is a surrogate marker of lung clearance index for assessment of adults with bronchiectasis.
   Guan WJ, Yuan JJ, Gao YH, Li HM, et al · · 2016 · cited 8× · PMID 27339787 · DOI 10.1038/srep28467