Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention
Primary Purpose
Bronchiectasis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
erythromycin
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis children
Eligibility Criteria
Inclusion Criteria:
All children participating in this clinical study must meet all of the following criteria.
- age: 0-18 years old, male and female;
- accord with diagnostic criteria of bronchiectasis;
- Agreed to retain specimens related to disease research and to store them in a sample bank;
- willing and able to cooperate with long term follow-up;
- the guardian of the child has a good understanding of the purpose of the study, a basic understanding of the clinical research program, and voluntary participation of the child in the study and the signing of an informed consent form.
Diagnostic criteria of bronchiectasis: clinical manifestation + one or more clinical manifestations of high-resolution computed tomography (HRCT):
- Clinical manifestations: recurrent cough, sputum, fixed wet rale in lung auscultation, clubbing finger (toe) and so on;
- HRCT was more than one of the following: (1) In the lung segment, some distal end of a bronchial cavity diameter greater than or equal to the proximal end. the distal end of the lumen was greater than or equal to the proximal end of a segment of the bronchus. (2)The diameter of bronchus is larger than that of accompanied pulmonary artery. (3) the bronchus was seen within the area of 1.0cm under the chest wall. (4)Compared with the adjacent bronchi, the inner diameter of the bronchus was obviously larger than that of the adjacent lung segment, and the wall of the bronchus was thicker than that of the adjacent lung segment.
Exclusion Criteria:
All children with any of the following conditions must be excluded from this study:
- children who are unable or unwilling to follow up regularly;
- who are unable or unwilling to provide information on the history of the disease, The development of the disease and the response after treatment and other information in children.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
low dose erythromycin group
Non-erythromycin treatment group
Arm Description
Erythromycin 3-5mg/kg.d orally for 6 months
systemic treatment
Outcomes
Primary Outcome Measures
Change from baseline in lung function on the spirometry
forced expiratory volume at one second (FEV1) in Liter
Secondary Outcome Measures
Frequencies of pulmonary exacerbation in children
Frequencies of pulmonary exacerbation
the number of dead people
the number of people who was dead
the changes of lung image
the changes of lung image
Full Information
NCT ID
NCT03966066
First Posted
January 28, 2019
Last Updated
August 25, 2019
Sponsor
Beijing Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03966066
Brief Title
Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention
Official Title
A Prospective, Multicenter Study on the Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
According to their compliance, the children were divided into two groups: low dose erythromycin treated group (erythromycin 3-5mg/kg.d orally for 6 months) and non-erythromycin treatment group. The quality of life score and acute exacerbation were evaluated during the observation period (6 months) and one year after the withdrawal of Erythromycin.The pulmonary imaging changes and the degree of deterioration in pulmonary function were compared between the two groups.
Detailed Description
Bronchiectasis is an important chronic pulmonary disease that endangers the health of children. It is characterized by recurrent respiratory tract infection, cough, massive pus sputum, hemoptysis, etc. The chronic progression of bronchiectasis may affect the lung function of children. It affects the quality of life, growth and development, and even leads to the death of children, and brings great harm to children and their families. A New Zealand study of non-cystic fibrotic bronchiectasis found that overall forced expiratory volume at one second (FEV1) declined at an average annual rate of 1.6%. Other studies have shown a significant decline in lung function in children with bronchiectasis even after treatment. Some reports on the prognosis of children with bronchiectasis in China show that most of the children have remission in clinical symptoms, but there are still some cases of chronic recurrence and death. A non-controlled study showed that adult bronchiectasis patients who received long-term azithromycin had fewer acute exacerbations and improved symptoms, which might be associated with the antimicrobial activity and anti-inflammatory of macrolide antibiotics. In children, the effect of macrolide antibiotics on cystic fibrosis is positive. Studies have shown that macrolides can effectively improve pulmonary function and reduce the incidence of acute exacerbation of pulmonary lesions. The course of treatment is at least 6 months. For non-cystic fibrosis bronchiectasis, recent studies have shown that long-term azithromycin treatment can reduce the exacerbation of pulmonary lesions. However, the treatment of bronchiectasis children in China is still lack of standard. The aim of this study was to explore the effect of macrolides on the long term prognosis of children with bronchiectasis in China, in order to standardize the treatment and improve the prognosis of the children with bronchiectasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose erythromycin group
Arm Type
Experimental
Arm Description
Erythromycin 3-5mg/kg.d orally for 6 months
Arm Title
Non-erythromycin treatment group
Arm Type
No Intervention
Arm Description
systemic treatment
Intervention Type
Drug
Intervention Name(s)
erythromycin
Other Intervention Name(s)
ERY
Intervention Description
3-5mg/kg.d orally for 6 months
Primary Outcome Measure Information:
Title
Change from baseline in lung function on the spirometry
Description
forced expiratory volume at one second (FEV1) in Liter
Time Frame
6 months, One year after the withdrawal
Secondary Outcome Measure Information:
Title
Frequencies of pulmonary exacerbation in children
Description
Frequencies of pulmonary exacerbation
Time Frame
6 months, One year after the withdrawal
Title
the number of dead people
Description
the number of people who was dead
Time Frame
6 months, One year after the withdrawal
Title
the changes of lung image
Description
the changes of lung image
Time Frame
6 months, One year after the withdrawal
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children participating in this clinical study must meet all of the following criteria.
age: 0-18 years old, male and female;
accord with diagnostic criteria of bronchiectasis;
Agreed to retain specimens related to disease research and to store them in a sample bank;
willing and able to cooperate with long term follow-up;
the guardian of the child has a good understanding of the purpose of the study, a basic understanding of the clinical research program, and voluntary participation of the child in the study and the signing of an informed consent form.
Diagnostic criteria of bronchiectasis: clinical manifestation + one or more clinical manifestations of high-resolution computed tomography (HRCT):
Clinical manifestations: recurrent cough, sputum, fixed wet rale in lung auscultation, clubbing finger (toe) and so on;
HRCT was more than one of the following: (1) In the lung segment, some distal end of a bronchial cavity diameter greater than or equal to the proximal end. the distal end of the lumen was greater than or equal to the proximal end of a segment of the bronchus. (2)The diameter of bronchus is larger than that of accompanied pulmonary artery. (3) the bronchus was seen within the area of 1.0cm under the chest wall. (4)Compared with the adjacent bronchi, the inner diameter of the bronchus was obviously larger than that of the adjacent lung segment, and the wall of the bronchus was thicker than that of the adjacent lung segment.
Exclusion Criteria:
All children with any of the following conditions must be excluded from this study:
children who are unable or unwilling to follow up regularly;
who are unable or unwilling to provide information on the history of the disease, The development of the disease and the response after treatment and other information in children.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baoping Xu, MD,PhD
Phone
861059616308
Ext
861059616308
Email
xubaopingbch@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
20627931
Citation
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.
Results Reference
background
PubMed Identifier
12383667
Citation
Equi A, Balfour-Lynn IM, Bush A, Rosenthal M. Long term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial. Lancet. 2002 Sep 28;360(9338):978-84. doi: 10.1016/s0140-6736(02)11081-6.
Results Reference
background
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Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention
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