Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseREASONNCT04259736
Prospective Cohort Study of Molecular Mechanism of Lower Respiratory Tract Microbes in Patients With AECOPD
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Microbiome, run by Huashan Hospital at 1 site in China.
Trial summary
How to reduce the rapid decline of lung function in patients with AECOPD is a clinically urgent problem to be solved. Studies have suggested that there is a bacterial flora imbalance in the lower respiratory tract of COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Microbiome
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2020
- How long will I take part?
- 1 Year
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. Patients will be followed up every 3 months for a period of 1 year.
Who may be able to join
- Patients with a diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) according to the GOLD2018 guidelines (patients with FEV1pred> 30% and no concurrent respiratory failure);
- Age ≥18, ≤80 years, regardless of gender;
- No antibiotics have been used after this acute exacerbation;
- Treatment according to GOLD guidelines;
- Those with the following bronchoscopy indications:
- Collect lower respiratory tract secretions for bacteriological examination;
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- Chest radiographs have invasive lesions of unknown origin;
- bronchoalveolar lavage, bronchial administration and suction treatment;
- unexplained hemoptysis or chronic irritating cough;
- Bronchial obstructions such as localized wheezing, localized emphysema, obstructive pneumonia, or any atelectasis;
- Suspected of trachea and bronchial tumors;
- paralysis of the recurrent laryngeal or phrenic nerve of unknown cause;
- Cancer cells or Mycobacterium tuberculosis are found in sputum and no lesions are found on chest radiograph;
- Suspected of bronchial foreign bodies or stones;
- diffuse lesions of the lungs or masses around the lungs that require lung biopsy, brushing, or lavage for cytology or bacteriological examination to confirm the diagnosis;
- Patients who have a long-term indwelling cannula after tracheotomy and know whether the trachea is damaged or necrotic;
- hilar swollen, unexplained lung mass;
- Select lipiodol or iodine radiography of a lung lobe or segment.
- Voluntary signed informed consent.
Who cannot join
- active phase of tuberculosis;
- Patients with malignant tumor disease;
- patients with rheumatic diseases;
- Patients with contraindications to bronchoscopy;
- patients with mental illness;
- Exclude those with severe medical diseases: such as heart, liver, and kidney dysfunction or coagulation dysfunction; uncontrolled hypertension, hyperglycemia or arrhythmia;
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- pregnancy and lactation;
- Patients who participated in other clinical trials in the past 3 months;
- Staff members and their families in this research institution.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan hospital,Fudan university
Shanghai, Shanghai Municipality, 200040
Shengqing Li, PhD, 02152887072, shengqingli9655@163.com
Jingwen Xia, MD, +8602152887072, xjw2006@126.com
About this study
Official title: A Prospective Cohort Study of Molecular Mechanism of Lower Respiratory Tract Microbes in Patients With Acute Obstructive Pulmonary Disease (AECOPD) by Regulating the Transcriptional Balance of NF-κB and PPARγ in Alveolar Macrophages
How to reduce the rapid decline of lung function in patients with AECOPD is a clinically urgent problem to be solved. Studies have suggested that there is a bacterial flora imbalance in the lower respiratory tract of COPD patients. To explore the relationship between microbiology and host immunity is a hot topic in the field of COPD. The investigators use NGS (next generation sequencing) technology to fully explore the specific molecular mechanism of the lower respiratory tract microbiome in patients with COPD by regulating the transcriptional activities of NF-κB and PPARγ in alveolar macrophages, resulting in pulmonary parenchymal remodeling and decreased lung function. In this study, a prospective cohort study will be used to evaluate the effect of the lower respiratory tract microbiome on lung tissue (alveolar space and pulmonary vascular) remodeling and pulmonary function decline in patients with AECOPD.
Read the detailed description
This study will be based on a prospective cohort design in patients with COPD who are eligible for the study. Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. The purpose of this study is to evaluate the effect of the lower respiratory tract microbiome on lung tissue remodeling, decreased lung function, and clinical symptoms in patients with AECOPD.
Baseline screening includes demographic data, medical history, combined medication records, symptoms, signs, symptom scores, number of acute exacerbations, blood cells and inflammatory factors, electrocardiogram, lung function, alveolar lavage fluid microbe NGS, and safety observation indicators.
Patients will be followed up every 3 months for a period of 1 year. The primary and secondary endpoints are as follows.
Primary endpoint： Changes in FEV1 (forced expiratory volume in the first second) within 1 year of follow-up
Secondary endpoint： Changes in CAT, CCQ, mMRC scores during 1 year of follow-up Changes in lung function during 1 year of follow-up: FEV1 / FVC Changes in blood routine, IgE, and eosinophil count within 1 year of follow-up Number of hospital admissions due to acute exacerbation during 1 year of follow-up
- Keywords
- Lower Respiratory Tract, Microbes, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume in the first second
Measured: 12 months
Secondary outcomes (4)
CAT scores
COPD Assessment Test score; Score: 0-10, Low impact; Score: 10-20, Moderate impact; Score 20-30, High impact; Score 30-40, Very high impact.
Measured: 12 months
mMRC scores
The modified British Medical ResearchCouncil (mMRC) questionnaire total score ranges from 0 to 4, with higher grades indicating more severe breathlessness.
Measured: 12 months
other lung function parameters
FEV1/ FVC
Measured: 12 months
Incidence of COPD exacerbation
Number of Incidence of COPD exacerbation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Huashan Hospital
- Investigators
- Shengqing Li, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259736
- Sponsor's protocol ID
- KY2018-362
- Acronym
- REASON
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Molecular Mechanism of Lower Respiratory Tract Microbes in Patients With Acute Obstructive Pulmonary Disease (AECOPD) by Regulating the Transcriptional Balance of NF-κB and PPARγ in Alveolar Macrophages
- ClinicalTrials.gov ID
- NCT04259736
- Acronym / sponsor ID
- REASON / KY2018-362
- Keywords
- Lower Respiratory Tract, Microbes, COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Feb 2020 (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.
How to reduce the rapid decline of lung function in patients with AECOPD is a clinically urgent problem to be solved. Studies have suggested that there is a bacterial flora imbalance in the lower respiratory tract of COPD patients. To explore the relationship between microbiology and host immunity is a hot topic in the field of COPD. The investigators use NGS (next generation sequencing) technology to fully explore the specific molecular mechanism of the lower respiratory tract microbiome in patients with COPD by regulating the transcriptional activities of NF-κB and PPARγ in alveolar macrophages, resulting in pulmonary parenchymal remodeling and decreased lung function. In this study, a prospective cohort study will be used to evaluate the effect of the lower respiratory tract microbiome on lung tissue (alveolar space and pulmonary vascular) remodeling and pulmonary function decline in patients with AECOPD.
Detailed description
This study will be based on a prospective cohort design in patients with COPD who are eligible for the study. Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. The purpose of this study is to evaluate the effect of the lower respiratory tract microbiome on lung tissue remodeling, decreased lung function, and clinical symptoms in patients with AECOPD.
Baseline screening includes demographic data, medical history, combined medication records, symptoms, signs, symptom scores, number of acute exacerbations, blood cells and inflammatory factors, electrocardiogram, lung function, alveolar lavage fluid microbe NGS, and safety observation indicators.
Patients will be followed up every 3 months for a period of 1 year. The primary and secondary endpoints are as follows.
Primary endpoint： Changes in FEV1 (forced expiratory volume in the first second) within 1 year of follow-up
Secondary endpoint： Changes in CAT, CCQ, mMRC scores during 1 year of follow-up Changes in lung function during 1 year of follow-up: FEV1 / FVC Changes in blood routine, IgE, and eosinophil count within 1 year of follow-up Number of hospital admissions due to acute exacerbation during 1 year of follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. Patients will be followed up every 3 months for a period of 1 year.
Key inclusion criteria (19 listed)
- Patients with a diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) according to the GOLD2018 guidelines (patients with FEV1pred> 30% and no concurrent respiratory failure);
- Age ≥18, ≤80 years, regardless of gender;
- No antibiotics have been used after this acute exacerbation;
- Treatment according to GOLD guidelines;
- Those with the following bronchoscopy indications:
Key exclusion criteria (9 listed)
- active phase of tuberculosis;
- Patients with malignant tumor disease;
- patients with rheumatic diseases;
- Patients with contraindications to bronchoscopy;
- patients with mental illness;
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
FEV1
Time frame: 12 months
Forced expiratory volume in the first second
4 secondary outcomes
CAT scores
Time frame: 12 months
mMRC scores
Time frame: 12 months
other lung function parameters
Time frame: 12 months
Incidence of COPD exacerbation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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. This study is not recruiting at the moment.
Shengqing Li, PhD principal investigator
Huashan Hospital
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 Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Microbiome, run by Huashan Hospital 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 19 inclusion and 9 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 6 Feb 2020. 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 Shengqing Li, PhD (+8602152887072, shengqingli9655@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: 12 months). 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 6 Feb 2020.