NCT03966066

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

January 28, 2019

Last Update Submit

August 25, 2019

Conditions

Bronchiectasis

Keywords

Bronchiectasis children

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in lung function on the spirometry

    forced expiratory volume at one second (FEV1) in Liter

    6 months, One year after the withdrawal

Secondary Outcomes (3)

  • Frequencies of pulmonary exacerbation in children

    6 months, One year after the withdrawal

  • the number of dead people

    6 months, One year after the withdrawal

  • the changes of lung image

    6 months, One year after the withdrawal

Study Arms (2)

low dose erythromycin group

EXPERIMENTAL

Erythromycin 3-5mg/kg.d orally for 6 months

Drug: erythromycin

Non-erythromycin treatment group

NO INTERVENTION

systemic treatment

Interventions

erythromycinDRUG

3-5mg/kg.d orally for 6 months

Also known as: ERY
low dose erythromycin group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20627931BACKGROUND

  • 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.

    PMID: 12383667BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Baoping Xu, MD,PhD

CONTACT

861059616308xubaopingbch@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Respiratory Department

Study Record Dates

First Submitted

January 28, 2019

First Posted

May 29, 2019

Study Start

August 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08