Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study

Bronchiectasis Clinical Trial

Official title:

Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02564731
• Other study ID #: BCHlung003
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2015
• Last updated: January 5, 2017
• Start date: June 2016
• Est. completion date: March 2022

Study information

• Verified date: January 2017
• Source: Beijing Children's Hospital
• Contact: Baoping Xu, MD,PhD
• Phone: 861059616308
• Email: xubaopingbch[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and TechnologyChina: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This prospective cohort study is designed to observe of the effect of intervention therapy on the long-term prognosis of children with bronchiectasis. The main purpose of the study was to evaluate the degree of deterioration of lung function, to observe and compare the quality of life, the time of pulmonary exacerbation, and the changes of lung image.

Description:

All enrolled patients are followed up for half a year, 1 years, 2 years, 3 years, 4 years, 5 years, while observation of pulmonary function, symptoms, signs, quality of life, the times of acute pulmonary exacerbation, and the changes of lung image are performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:A included patient must be coincident at least one point of the four items of high-resolution computed tomography (HRCT) manifestations.

• Internal bronchial diameter greater than the accompanying pulmonary artery.

• lack of bronchial tapering

• bronchi visible in the peripheral 1cm of lung

• bronchial diameter greater than adjacent segmental bronchi

Exclusion Criteria:Subject will be excluded if she or he has one of the following

• It is unable or doesn't agree to accept the follow-up process

• undergoing trial for other medications or instruments.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
China	Beijing Children'S Hospital	Beijing	Beijing

Sponsors (14)

Lead Sponsor

Collaborator

Baoping XU

Children's Hospital of Changchun, Children's Hospital of Chongqing Medical University, Children's Hospital of Fudan University, First Affiliated Hospital of Guangxi Medical University, Jiangxi Province Children's Hospital, Shanghai Children's Medical Center, Shanxi Children's Hospital, Shenzhen Children's Hospital, The Affiliated Hospital Of Guizhou Medical University, The First Affiliated Hospital of Xiamen University, Tianjin Children's Hospital, Wuhan women and children's health care center, Yuying Children's Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

CHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.

Davies G, Wilson R. Prophylactic antibiotic treatment of bronchiectasis with azithromycin. Thorax. 2004 Jun;59(6):540-1. — View Citation

Gaylor AS, Reilly JC. Therapy with macrolides in patients with cystic fibrosis. Pharmacotherapy. 2002 Feb;22(2):227-39. Review. — View Citation

Karakoc GB, Yilmaz M, Altintas DU, Kendirli SG. Bronchiectasis: still a problem. Pediatr Pulmonol. 2001 Aug;32(2):175-8. — View Citation

Munro KA, Reed PW, Joyce H, Perry D, Twiss J, Byrnes CA, Edwards EA. Do New Zealand children with non-cystic fibrosis bronchiectasis show disease progression? Pediatr Pulmonol. 2011 Feb;46(2):131-8. doi: 10.1002/ppul.21331. — View Citation

Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. — View Citation

Twiss J, Stewart AW, Byrnes CA. Longitudinal pulmonary function of childhood bronchiectasis and comparison with cystic fibrosis. Thorax. 2006 May;61(5):414-8. — View Citation

Valery PC, Morris PS, Byrnes CA, Grimwood K, Torzillo PJ, Bauert PA, Masters IB, Diaz A, McCallum GB, Mobberley C, Tjhung I, Hare KM, Ware RS, Chang AB. Long-term azithromycin for Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease (Bronchiectasis Intervention Study): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2013 Oct;1(8):610-20. doi: 10.1016/S2213-2600(13)70185-1. Erratum in: Lancet Respir Med. 2015 Aug;3(8):e29. — View Citation

WANG Hao,XU Bao-ping,LIU Xiu-yun,HU Ying-hui,REN Yi-xin,SHEN Kun-ling. Clinical characteristics and follow-up of bronchiectasis in children. Chinese Journal of Practical Pediatrics, 2014;29 (12):936-939

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in lung function on the spirometry	forced expiratory volume at one second (FEV1) in Liter	5 years	No