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Bacteriology and Inflammation in Bronchiectasis (BISER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01761214
Recruitment Status : Recruiting
First Posted : January 4, 2013
Last Update Posted : February 11, 2020
Information provided by (Responsible Party):
Weijie Guan, Guangzhou Institute of Respiratory Disease

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Fluroquinolones Drug: Beta-lactamase inhibitor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bacteriology and Sputum and Systemic Inflammation in Steady-state, Acute Exacerbation and Recovery of Bronchiectasis
Actual Study Start Date : September 2012
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Active Comparator: Fluroquinolones
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
All antibiotics are administered based on British Thoracic Society guideline for bronchiectasis
Other Names:
  • levoflocaxin (Cravit)
  • moxifloxacin (Avelox)
  • ciprofloxacin (Cifran)

Active Comparator: Beta-lactamase inhibitor
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
All antibiotics are administered based on British Thoracic Society guideline for bronchiectasis.
Other Name: amoxicillin clavulanate potassium compound (Junerqing)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Sputum sol phase inflammatory indices [ Time Frame: 1 year ]
    sputum sol phase interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), leukotriene B4 (LTB4), myeloperoxidase (MPO) and C-reactive protein (CRP)

  2. 24-hour sputum volume [ Time Frame: 1 year ]

    Eligible patients with bronchiectasis, following recruitment, will be instructed to record the condition of expectoration in the patient diary card. This includes recording of 24-hour sputum volume, sputum purulence and changes in the symptoms per day. A minimum of 3 daily records between two neighboring visits are required. The 24-hour sputum volume will be recorded as the mean of 3 records.

    The volume of 24-hour sputum was recorded as the mean of the nearest 3 consecutive days. Sputum volume was scored for 1, 2, 3, 4, 5 and 6 points corresponding to 0-10ml, 10-20ml, 20-30ml, 30-40ml, 40-50ml and >50ml, respectively.

  3. Spirometry [ Time Frame: 1 year ]

    Spirometric indices in the present study is referred to as FEV1, FVC, FEV1/FVC and MMEF.

    Spirometry tests are carried out using a spirometer (COSMED, QUARK PFT, Italy). All operation procedures meet the joint recommendation by ATS and ERS. A total of at least 3 (not more than 8) spirometric maneuvers are performed, with the variation between the best two maneuvers of <5% or 200ml in FVC and FEV1. The maximal values of FVC and FEV1 are reported. MMEF is chosen from the maneuver with the highest sum of FVC and FEV1. The predicted values are selected based on the reference regression model established by Zheng JP and Zhong NS.

  4. Sputum purulence [ Time Frame: 1 year ]

    Patients receive chest physical therapy 15 minutes upon arrival at the hospital till expectoration complete. Patients are instructed to be seated and remove contents in the oral cavity followed by sputum collection using a sterile container between 10:00 a.m. and 12:00 a.m., an hour after physical therapy.

    Sputum purulence is scored for 1, 2, 3, 4, 5, 6 and 7 points corresponding to complete absence, almost translucent, half translucent, translucent but colorless, opaque and white, grey and green, moderately green and dark green, respectively. The specimen with highest score is selected for reports.

  5. Sputum viscosity [ Time Frame: 1 year ]
    Sputum viscosity is assessed by using a stick to randomly pick up the sputum from the center of the specimen. Sputum viscosity is scored for 1, 2 and 3 corresponding to mildly, moderately and severely sticky, respectively.

  6. SGRQ total score and the score of each domain [ Time Frame: 1 year ]
  7. Time to recovery of respective symptom [ Time Frame: 1 year ]
    The symptoms of bronchiectasis include cough, expectoration (referred to as 24-hour sputum volume, purulence and viscosity), chest pain, chest distress, wheezing, febrile, malaise, fatigue, tachypnea and hemoptysis. A significant amelioration (>20%) in the respective symptom during antibiotic treatment when compared with that of acute exacerbation is deemed as recovery. The time of recovery is mainly determined by patient self-reporting.

  8. Sputum bacterial clearance rate [ Time Frame: 1 year ]
    Sputum bacterial clearance rate is defined as the proportion of subjects who test negatively to sputum microbiology following a 14-day antibiotic therapy, with exception of those who showed a negative sputum culture profile during the steady-state bronchiectasis.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01761214

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China, Guangdong
State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Nan-shan Zhong, M. D.    020-83062718   
Contact: Rong-chang Chen, M. D.    020-83062718   
Sub-Investigator: Wei-jie Guan, Ph. D.         
Sub-Investigator: Zhi-ya Lin, Ph. D.         
Principal Investigator: Nan-shan Zhong, M. D.         
Principal Investigator: Rong-chang Chen, M. D.         
Sub-Investigator: Yong-hua Gao, Ph. D.         
Sub-Investigator: Gang Xu, Ph. D.         
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
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Principal Investigator: 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
Publications of Results:
Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Weijie Guan, Professor, Guangzhou Institute of Respiratory Disease Identifier: NCT01761214    
Other Study ID Numbers: SKLRD-2013-GWJ
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Keywords provided by Weijie Guan, Guangzhou Institute of Respiratory Disease:
bacteriology, inflammation, bronchiectasis, exacerbation
Additional relevant MeSH terms:
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Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
beta-Lactamase Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors