BronchiectasisNCT02564731
Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study
An observational study of Bronchiectasis, run by Baoping XU at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)
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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children'S Hospital
Beijing, Beijing Municipality, 100045
baoping xu
About this study
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.
Read the detailed 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.
- Conditions
- Bronchiectasis
- Keywords
- children, prognosis
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lung function on the spirometry
forced expiratory volume at one second (FEV1) in Liter
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baoping XU
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan women and children's health care center, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Changchun Children's Hospital, Shenzhen Children's Hospital, Jiangxi Province Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Tianjin Children's Hospital, The First Affiliated Hospital of Xiamen University, Children's Hospital of Fudan University, The Affiliated Hospital Of Guizhou Medical University, Shanxi Provincial Maternity and Children's Hospital
- Responsible party
- Sponsor-investigator, Baoping XU, Beijing Children's Hospital
- Investigators
- Kunling Shen, MD,PhD, Study director, Beijing Children's Hospital of Capital Medical University, ChinaBaoping Xu, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, ChinaXiaoxia Peng, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564731
- Sponsor's protocol ID
- BCHlung003
- Status last verified
- Jan 2017
- First submitted
- 14 Sep 2015
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11477735Munro 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.
PubMed 20717910Twiss 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.
PubMed 16467074Murray 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.
PubMed 19541717Davies G, Wilson R. Prophylactic antibiotic treatment of bronchiectasis with azithromycin. Thorax. 2004 Jun;59(6):540-1. No abstract available.
PubMed 15170047Valery 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.
PubMed 24461664Gaylor 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.
PubMed 11837560WANG 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
CHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02564731
- Acronym / sponsor ID
- BCHlung003
- Conditions
- Bronchiectasis
- Keywords
- children, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baoping XUUniversity, hospital or other
- Collaborators
- Wuhan women and children's health care center, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Changchun Children's Hospital, Shenzhen Children's Hospital, Jiangxi Province Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Tianjin Children's Hospital, The First Affiliated Hospital of Xiamen University, Children's Hospital of Fudan University, The Affiliated Hospital Of Guizhou Medical University, Shanxi Provincial Maternity and Children's Hospital
- Study start
- Jun 2016
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in lung function on the spirometry
Time frame: 5 years
forced expiratory volume at one second (FEV1) in Liter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 11477735Karakoc GB, Yilmaz M, Altintas DU, Kendirli SG. Bronchiectasis: still a problem. Pediatr Pulmonol. 2001 Aug;32(2):175-8. doi: 10.1002/ppul.1104.
- Background: PubMed 20717910Munro 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.
- Background: PubMed 16467074Twiss 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.
- Background: PubMed 19541717Murray 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.
- Background: PubMed 15170047Davies G, Wilson R. Prophylactic antibiotic treatment of bronchiectasis with azithromycin. Thorax. 2004 Jun;59(6):540-1. No abstract available.
- Background: PubMed 24461664Valery 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.
- Background: PubMed 11837560Gaylor 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.
- BackgroundWANG 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
- BackgroundCHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunling Shen, MD,PhD study director
Beijing Children's Hospital of Capital Medical University, China
Baoping Xu, MD,PhD principal investigator
Beijing Children's Hospital of Capital Medical University, China
Xiaoxia Peng, MD,PhD principal investigator
Beijing Children's Hospital of Capital Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Baoping XU at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baoping Xu, MD,PhD (861059616308, xubaopingbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in lung function on the spirometry (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564731, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.