NCT02564731

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 14, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

September 14, 2015

Last Update Submit

January 5, 2017

Conditions

Bronchiectasis

Keywords

childrenprognosis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in lung function on the spirometry

    forced expiratory volume at one second (FEV1) in Liter

    5 years

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)

You may qualify if:

  • 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

You may not qualify if:

  • It is unable or doesn't agree to accept the follow-up process
  • undergoing trial for other medications or instruments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children'S Hospital

Beijing, Beijing Municipality, 100045, China

RECRUITING

Related Publications (9)

  • Karakoc GB, Yilmaz M, Altintas DU, Kendirli SG. Bronchiectasis: still a problem. Pediatr Pulmonol. 2001 Aug;32(2):175-8. doi: 10.1002/ppul.1104.

    PMID: 11477735BACKGROUND

  • 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. Epub 2010 Aug 17.

    PMID: 20717910BACKGROUND

  • Twiss J, Stewart AW, Byrnes CA. Longitudinal pulmonary function of childhood bronchiectasis and comparison with cystic fibrosis. Thorax. 2006 May;61(5):414-8. doi: 10.1136/thx.2005.047332. Epub 2006 Feb 7.

    PMID: 16467074BACKGROUND

  • 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. Epub 2009 Jun 18.

    PMID: 19541717BACKGROUND

  • Davies G, Wilson R. Prophylactic antibiotic treatment of bronchiectasis with azithromycin. Thorax. 2004 Jun;59(6):540-1. No abstract available.

    PMID: 15170047BACKGROUND

  • 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):610-620. doi: 10.1016/S2213-2600(13)70185-1. Epub 2013 Sep 17.

    PMID: 24461664BACKGROUND

  • Gaylor AS, Reilly JC. Therapy with macrolides in patients with cystic fibrosis. Pharmacotherapy. 2002 Feb;22(2):227-39. doi: 10.1592/phco.22.3.227.33544.

    PMID: 11837560BACKGROUND

  • 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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Kunling Shen, MD,PhD

    Beijing Children's Hospital of Capital Medical University, China

    STUDY DIRECTOR

  • Baoping Xu, MD,PhD

    Beijing Children's Hospital of Capital Medical University, China

    PRINCIPAL INVESTIGATOR

  • Xiaoxia Peng, MD,PhD

    Beijing Children's Hospital of Capital Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baoping Xu, MD,PhD

CONTACT

861059616308xubaopingbch@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Respiratory Department

Study Record Dates

First Submitted

September 14, 2015

First Posted

October 1, 2015

Study Start

June 1, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

CN(1)