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Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention

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ClinicalTrials.gov Identifier: NCT03966066
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Baoping XU, Beijing Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: erythromycin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Study on the Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low dose erythromycin group
Erythromycin 3-5mg/kg.d orally for 6 months
Drug: erythromycin
3-5mg/kg.d orally for 6 months
Other Name: ERY

No Intervention: Non-erythromycin treatment group
systemic treatment



Primary Outcome Measures :
  1. Change from baseline in lung function on the spirometry [ Time Frame: 6 months, One year after the withdrawal ]
    forced expiratory volume at one second (FEV1) in Liter


Secondary Outcome Measures :
  1. Frequencies of pulmonary exacerbation in children [ Time Frame: 6 months, One year after the withdrawal ]
    Frequencies of pulmonary exacerbation

  2. the number of dead people [ Time Frame: 6 months, One year after the withdrawal ]
    the number of people who was dead

  3. the changes of lung image [ Time Frame: 6 months, One year after the withdrawal ]
    the changes of lung image



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03966066


Contacts
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Contact: Baoping Xu, MD,PhD 861059616308 ext 861059616308 xubaopingbch@163.com

Sponsors and Collaborators
Beijing Children's Hospital

Publications:
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Responsible Party: Baoping XU, Chief of Respiratory Department, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT03966066     History of Changes
Other Study ID Numbers: BCHlung010
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baoping XU, Beijing Children's Hospital:
Bronchiectasis children
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action