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

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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

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.
    


Study Type

Interventional


Primary Outcome

Change from baseline in lung function on the spirometry

Secondary Outcome

 Frequencies of pulmonary exacerbation in children

Condition

Bronchiectasis

Intervention

erythromycin

Study Arms / Comparison Groups

 low dose erythromycin group
Description:  Erythromycin 3-5mg/kg.d orally for 6 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

August 2019

Completion Date

July 2020

Primary Completion Date

July 2020

Eligibility 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.
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

, 861059616308, [email protected]



Administrative Informations


NCT ID

NCT03966066

Organization ID

BCHlung010


Responsible Party

Principal Investigator

Study Sponsor

Beijing Children's Hospital


Study Sponsor

, , 


Verification Date

August 2019