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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
Beijing Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis children

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All children participating in this clinical study must meet all of the following criteria.

  1. age: 0-18 years old, male and female;
  2. accord with diagnostic criteria of bronchiectasis;
  3. Agreed to retain specimens related to disease research and to store them in a sample bank;
  4. willing and able to cooperate with long term follow-up;
  5. 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):

  1. Clinical manifestations: recurrent cough, sputum, fixed wet rale in lung auscultation, clubbing finger (toe) and so on;
  2. 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:

  1. children who are unable or unwilling to follow up regularly;
  2. 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

    First Posted
    January 28, 2019
    Last Updated
    August 25, 2019
    Sponsor
    Beijing Children's Hospital
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    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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