Bacteriology and Inflammation in Bronchiectasis
Information source: Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiectasis
Intervention: Fluroquinolones (Drug); Beta-lactamase inhibitor (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Guangzhou Institute of Respiratory Disease Official(s) and/or principal investigator(s): Nan-shan Zhong, M. D., Principal Investigator, Affiliation: Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College Rong-chang Chen, M. D., Principal Investigator, Affiliation: Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
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.
Clinical Details
Official title: Bacteriology and Sputum and Systemic Inflammation in Steady-state, Acute Exacerbation and Recovery of Bronchiectasis
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sputum microbiology
Secondary outcome: Sputum sol phase inflammatory indices24-hour sputum volume Spirometry Sputum purulence Sputum viscosity SGRQ total score and the score of each domain Time to recovery of respective symptom Sputum bacterial clearance rate
Detailed description:
Bronchiectasis is a chronic disease arises from progressive airway inflammation and
infection. Pro-inflammatory mediators, the products of activated neutrophils recruited to
the inflamed sites, are released in bronchiectatic airways and mediate cascades of
neutrophil infiltration. This suggests that bacterial infection plays a pivotal role in the
neutrophil-derived inflammation leading to the vicious cycle that perpetuates the
development of airway destruction and might result in acute exacerbation. Treatments
targeting at bacterial infection is therefore necessary, particularly for those with acute
exacerbation of bronchiectasis.
Although short- and long-term administration of antibiotics have been evidenced to markedly
suppress bacterial colonization and inflammatory indices, the roles that potent antibiotics
play in patients with exacerbation of bronchiectasis are unclear. The assessment of
bacterial infection and sputum and systemic inflammation during steady-state, acute
exacerbation and recovery from exacerbation of bronchiectasis may clinically shed light on
and indicate the efficacy of antibiotic treatments.
Furthermore, a subgroup of patients may experience the acute exacerbation that may stem from
non-bacterial pathogens. There has been a dire need to compare the changes in sputum
bacterial load and inflammatory indices based on sputum bacteriology. This may help uncover
the mechanism of different responses to antibiotic treatment in patients who had varying
bacteriologic profiles.
Unlike assessment of chronic obstructive pulmonary disease, few clinical indices for
appraisal of onset of exacerbation and efficacy of treatments are available. Of these, the
24-hour sputum volume, microbial clearance, C-reactive protein (CRP) and St George's
Respiratory Questionnaire have been validated. In the present study, we employed sputum
bacteriology and inflammatory indices, including the aforementioned parameters, for
assessment.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients of either sex and age between 18 and 70 years
Exclusion Criteria:
- 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
Locations and Contacts
State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong 510120, China; Recruiting Nan-shan Zhong, M. D., Phone: 020-83062718, Email: nanshan@vip.163.com Rong-chang Chen, M. D., Phone: 020-83062718, Email: chenrc99@hotmail.com Wei-jie Guan, Ph. D., Sub-Investigator Zhi-ya Lin, Ph. D., Sub-Investigator Nan-shan Zhong, M. D., Principal Investigator Rong-chang Chen, M. D., Principal Investigator Yong-hua Gao, Ph. D., Sub-Investigator Gang Xu, Ph. D., Sub-Investigator
Additional Information
Related publications: Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. Review. 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. Review. 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. 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. 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. Review. 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. 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. Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. Zheng J, Zhong N. Normative values of pulmonary function testing in Chinese adults. Chin Med J (Engl). 2002 Jan;115(1):50-4.
Starting date: September 2012
Last updated: March 9, 2015
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