DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 indices

24-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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017