BronchiectasisNCT03966066
Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention
A study testing erythromycin in people with Bronchiectasis, run by Beijing Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- erythromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter Study on the Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin
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.
Read the 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.
- Conditions
- Bronchiectasis
- Being tested
- erythromycin
- Keywords
- Bronchiectasis children
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythromycinDrug
Also called ERY
3-5mg/kg.d orally for 6 months
| Study group | Role | What they receive |
|---|---|---|
| low dose erythromycin group | Experimental | Erythromycin 3-5mg/kg.d orally for 6 months Receives: Drug: erythromycin |
| Non-erythromycin treatment group | No intervention | systemic treatment |
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: 6 months, One year after the withdrawal
Secondary outcomes (3)
Frequencies of pulmonary exacerbation in children
Frequencies of pulmonary exacerbation
Measured: 6 months, One year after the withdrawal
the number of dead people
the number of people who was dead
Measured: 6 months, One year after the withdrawal
the changes of lung image
the changes of lung image
Measured: 6 months, One year after the withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study startAug 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoping XU, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966066
- Sponsor's protocol ID
- BCHlung010
- Status last verified
- Aug 2019
- First submitted
- 28 Jan 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20627931Equi 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.
PubMed 12383667
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study on the Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin
- ClinicalTrials.gov ID
- NCT03966066
- Acronym / sponsor ID
- BCHlung010
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 29 May 2019 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose erythromycin group | Experimental | Drug: erythromycinErythromycin 3-5mg/kg.d orally for 6 months |
| Non-erythromycin treatment group | No intervention | –systemic treatment |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythromycinAlso: ERY3-5mg/kg.d orally for 6 months | Drug | low dose erythromycin group |
Primary outcome
Change from baseline in lung function on the spirometry
Time frame: 6 months, One year after the withdrawal
forced expiratory volume at one second (FEV1) in Liter
3 secondary outcomes
Frequencies of pulmonary exacerbation in children
Time frame: 6 months, One year after the withdrawal
the number of dead people
Time frame: 6 months, One year after the withdrawal
the changes of lung image
Time frame: 6 months, One year after the withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 20627931Pasteur 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.
- Background: PubMed 12383667Equi 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing erythromycin in people with Bronchiectasis, run by Beijing Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 ext. 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: 6 months, One year after the withdrawal). 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 NCT03966066, which also lists 2 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 28 Aug 2019.