BronchiectasisNCT04966793
Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasis Patients.
An observational study of Bronchiectasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Qualified sputum samples from bronchiectasis patients were collected regularly every month for three consecutive years to analyze the microbiome changes of lower respiratory tract of bronchiectasis patients by metagenomic sequencing. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- How many people
- 1,850 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2020to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bronchiectasis patients aged 18 to 79.
Who may be able to join
- Bronchiectasis patients in clinically stable period;
- Two or more chest infections in the previous year;
- Chest CT confirmed bronchiectasis (bronchial to arterial ratio >1).
- Chronic colonization of pseudomonas aeruginosa and was clinically stable in 6 months prior to the study.
Who cannot join
- deterioration of illness (defined as at least 24 hours of three or more of the following symptoms: increased cough, increased sputum volume, purulent sputum, hemoptysis, increased dyspnea, increased wheezing, fever ((≥38°C) or discomfort, the attending physician agrees that antibiotic treatment is required);
- current smokers, or former smokers who have stopped smoking less than 1 year ago, have a history of more than 15 packets of age, or CT showed as emphysema;
- cystic fibrosis patients;
- active allergic bronchopulmonary aspergillosis;
- active tuberculosis patients;
- patients with poor asthma control;
- pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasia Patients.
Qualified sputum samples from bronchiectasis patients were collected regularly every month for three consecutive years to analyze the microbiome changes of lower respiratory tract of bronchiectasis patients by metagenomic sequencing. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution，including virulence, quorum sensing and drug resistance under host pressure. The aim of the study is to clarify the rule of microflora colonization distribution and adaptive evolution in the lower respiratory tract of patients with bronchiectasis, to predict the acute attack and prognosis of patients with microbiome changes, and to find more new prevention and treatment methods by adjusting the microbiome of the lower respiratory tract.
Read the detailed description
Bronchiectasis is an abnormal, permanent dilatation of the bronchi, which presents as cough, expectoration and recurrent pulmonary infections. Epidemiological survey researchs have found that the number of bronchiectasis has increased rather than decreased in the last decades. Asia has the highest prevalence of bronchiectasis, with 1,200 cases in every 100,000 people over the age of 40 in China, and this rate can be seriously underestimated due to difficulties in identifying COPD. The mortality rate of bronchiectasis patients is more than twice that of the general population, placing an increasing burden on global health care systems. Chronic infection in bronchiectasis is common and had a big influence on prognosis. Pseudomonas aeruginosa is considered to be the most common colonization bacterium. At present, the mechanism of bronchiectasis and its relationship with lower respiratory tract infection have not been fully elucidated. Therefore, it is important to have an in-depth understanding of the colonization distribution and adaptive evolution of the microbiome in the lower respiratory tract, to predict the acute attack and prognosis with the application of microbiome changes, and to find more new and effective prevention and treatment methods by regulating the microbiome in the lower respiratory tract. Qualified sputum specimens from bronchiectasis patients were collected regularly every month for three consecutive years. Metagenomic sequencing was used to analyze the microbiome changes of lower respiratory tract in these patients. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution of its virulence, group sensitivity and drug resistance under host pressure.
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Microbiology
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis patients group | Bronchiectasis patients group: Sputum specimens from bronchiectasis patients aged 18 to 79 years old . | |
| Healthy control group | Healthy control group: Sputum specimens from healthy people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline SNP of PA population in sputum samples
To assess the SNP changes of PA population in sputum samples compared with PAO1 wildtype
Measured: once per 3 month for 3 years
Species richness and antibiotic suscepibility change from baseline in sputum samples
To assess the species richness and antibiotic suscepibility change from baseline in sputum samples
Measured: once per 3 month for 3 years
Secondary outcomes (5)
pulmonary function
To assess the lung functon change
Measured: once per year for 3 years
chest CT
To assess the severity of lung lesions
Measured: once per year for 3 years
BSI scores
To assess the severity index of bronchiectasis.
Measured: once per year for 3 years
E-FACED scores
To assess the severity index of bronchiectasis.
Measured: once per year for 3 years
SGRQ questionnaire
To assess the impaired health and quality of life of patients with respiratory diseases
Measured: once per year for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start20 Feb 2020
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 1,850 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Xuanwu Hospital, Beijing, The Affiliated Jiangning Hospital of Nanjing Medical University, Tongji Hospital, Huadong Hospital, Beijing Chao Yang Hospital, Beijing Chest Hospital, Capital Medical University, The Affiliated Hospital of Qingdao University, Shandong Public Health Clinical Center, The First Medical Center of Chinese PLA General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966793
- Sponsor's protocol ID
- 2020-066
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Colonization Distribution and Adaptive Evolution of Lower Respiratory Tract in Bronchiectasia Patients.
- ClinicalTrials.gov ID
- NCT04966793
- Acronym / sponsor ID
- 2020-066
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Microbiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,850 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Xuanwu Hospital, Beijing, The Affiliated Jiangning Hospital of Nanjing Medical University, Tongji Hospital, Huadong Hospital, Beijing Chao Yang Hospital, Beijing Chest Hospital, Capital Medical University, The Affiliated Hospital of Qingdao University, Shandong Public Health Clinical Center, The First Medical Center of Chinese PLA General Hospital
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Jul 2021 (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.
Qualified sputum samples from bronchiectasis patients were collected regularly every month for three consecutive years to analyze the microbiome changes of lower respiratory tract of bronchiectasis patients by metagenomic sequencing. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution，including virulence, quorum sensing and drug resistance under host pressure. The aim of the study is to clarify the rule of microflora colonization distribution and adaptive evolution in the lower respiratory tract of patients with bronchiectasis, to predict the acute attack and prognosis of patients with microbiome changes, and to find more new prevention and treatment methods by adjusting the microbiome of the lower respiratory tract.
Detailed description
Bronchiectasis is an abnormal, permanent dilatation of the bronchi, which presents as cough, expectoration and recurrent pulmonary infections. Epidemiological survey researchs have found that the number of bronchiectasis has increased rather than decreased in the last decades. Asia has the highest prevalence of bronchiectasis, with 1,200 cases in every 100,000 people over the age of 40 in China, and this rate can be seriously underestimated due to difficulties in identifying COPD. The mortality rate of bronchiectasis patients is more than twice that of the general population, placing an increasing burden on global health care systems. Chronic infection in bronchiectasis is common and had a big influence on prognosis. Pseudomonas aeruginosa is considered to be the most common colonization bacterium. At present, the mechanism of bronchiectasis and its relationship with lower respiratory tract infection have not been fully elucidated. Therefore, it is important to have an in-depth understanding of the colonization distribution and adaptive evolution of the microbiome in the lower respiratory tract, to predict the acute attack and prognosis with the application of microbiome changes, and to find more new and effective prevention and treatment methods by regulating the microbiome in the lower respiratory tract. Qualified sputum specimens from bronchiectasis patients were collected regularly every month for three consecutive years. Metagenomic sequencing was used to analyze the microbiome changes of lower respiratory tract in these patients. Pseudomonas aeruginosa was isolated and the whole genome was sequenced to analyze the adaptive evolution of its virulence, group sensitivity and drug resistance under host pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis patients group | – | –Bronchiectasis patients group: Sputum specimens from bronchiectasis patients aged 18 to 79 years old . |
| Healthy control group | – | –Healthy control group: Sputum specimens from healthy people. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bronchiectasis patients aged 18 to 79.
Key inclusion criteria (4 listed)
- Bronchiectasis patients in clinically stable period;
- Two or more chest infections in the previous year;
- Chest CT confirmed bronchiectasis (bronchial to arterial ratio >1).
- Chronic colonization of pseudomonas aeruginosa and was clinically stable in 6 months prior to the study.
Key exclusion criteria (7 listed)
- deterioration of illness (defined as at least 24 hours of three or more of the following symptoms: increased cough, increased sputum volume, purulent sputum, hemoptysis, increased dyspnea, increased wheezing, fever ((≥38°C) or discomfort, the attending physician agrees that antibiotic treatment is required);
- current smokers, or former smokers who have stopped smoking less than 1 year ago, have a history of more than 15 packets of age, or CT showed as emphysema;
- cystic fibrosis patients;
- active allergic bronchopulmonary aspergillosis;
- active tuberculosis patients;
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 SNP of PA population in sputum samples
Time frame: once per 3 month for 3 years
To assess the SNP changes of PA population in sputum samples compared with PAO1 wildtype
Species richness and antibiotic suscepibility change from baseline in sputum samples
Time frame: once per 3 month for 3 years
To assess the species richness and antibiotic suscepibility change from baseline in sputum samples
5 secondary outcomes
pulmonary function
Time frame: once per year for 3 years
chest CT
Time frame: once per year for 3 years
BSI scores
Time frame: once per year for 3 years
E-FACED scores
Time frame: once per year for 3 years
SGRQ questionnaire
Time frame: once per year for 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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.
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 Second Affiliated Hospital, Zhejiang University, School of Medicine 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?
The sponsor lists 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Xu, Doctor (13666697918, xufeng99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline SNP of PA population in sputum samples (time frame: once per 3 month for 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.