Chronic Obstructive Pulmonary DiseaseNCT05681364
Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
An observational study of Chronic Obstructive Pulmonary Disease and Bronchiectasis, run by Peking University Third Hospital.
Trial summary
To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Bronchiectasis
- What is being tested?
- metabonomics
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients in respiratory and critical care medicine department of Peking University Third Hospital
Who may be able to join
- For COPD
- Meets the Global initiative for chronic obstructive lung disease (GOLD) 2022 definition of stable COPD;
- Age 30-75 years;
- Lung CT images only showed chronic bronchitis and emphysema;
- Agree to participate in the study and is able to cooperate with exhaled breath condensate collection.
- For bronchiectasis
Show all 9Show fewer
- Lung CT showed bronchiectasis;
- Age 18-75 years;
- Spirometry suggests obstructive ventilatory dysfunction: forced expiratory volume in one second (FEV1) is less than 70% of forced vital capacity (FVC) post bronchodilator inhalation.
Who cannot join
- Asthma or other respiratory diseases
- History of pulmonary surgery
- α1 antitrypsin deficiency
- Autoimmune diseases
- Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage
- A history of malignant disease now or within 2 years
Show all 11Show fewer
- History of acute exacerbation or change of medication in the past 4 weeks
- A history of blood transfusion within the last 4 weeks
- Drugs or alcohol abuse
- Breastfeeding or pregnant women
- Unable to cooperate with pulmonary rehabilitation for various reasons
Trial locations and contacts
No sites are listed yet.
About this study
To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model.
- Being tested
- metabonomics
- Keywords
- pulmonary rehabilitation, chronic respiratory disease, metabonomics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabonomicsOther
profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| COPD and bronchiectasis patients with some metabolic profiling | The patients with stable COPD and bronchiectasis who meet the screening criteria and with some metabolic profiling according to the previous studies. Receives: Other: metabonomics | |
| COPD and bronchiectasis patients without the metabolic profiling | The patients with stable COPD and bronchiectasis who meet the screening criteria and without the metabolic profiling according to the previous studies. Receives: Other: metabonomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary rehabilitation outcome
Systemic multidimensional measurements （SMM） will be used to evaluate the outcomes of PR program, the patients will be grouped in very good, good, moderate and poor responders by cluster analysis.
SMM are as follows: changes in the degree of dyspnea will be measured using the modified Medical Research Council scale; the St George's Respiratory Questionnaire will be use to evaluate changes in health status; exercise performance will be measured by a 6-min walk test and a constant work-rate test; the Canadian Occupational Performance Measure will be used to identify specific problematic activities of daily life; patients scored how well they were performing the problematic activities of daily life and how satisfied they were with this level of performance; symptoms of anxiety and depression will be measured by Hospital Anxiety and Depression Scale. The efficacy of the PR program of the whole sample will be evaluated based on the minimal clinically importance.
Measured: At week 12 of pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Wang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681364
- Sponsor's protocol ID
- 01
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05681364
- Acronym / sponsor ID
- 01
- Keywords
- pulmonary rehabilitation, chronic respiratory disease, metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jan 2023 (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.
To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD and bronchiectasis patients with some metabolic profiling | – | Other: metabonomicsThe patients with stable COPD and bronchiectasis who meet the screening criteria and with some metabolic profiling according to the previous studies. |
| COPD and bronchiectasis patients without the metabolic profiling | – | Other: metabonomicsThe patients with stable COPD and bronchiectasis who meet the screening criteria and without the metabolic profiling according to the previous studies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients in respiratory and critical care medicine department of Peking University Third Hospital
Key inclusion criteria (9 listed)
- For COPD
- For bronchiectasis
Key exclusion criteria (11 listed)
- Asthma or other respiratory diseases
- History of pulmonary surgery
- α1 antitrypsin deficiency
- Autoimmune diseases
- Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage
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 |
|---|---|---|
| metabonomicsprofiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation | Other | COPD and bronchiectasis patients with some metabolic profiling, COPD and bronchiectasis patients without the metabolic profiling |
Primary outcome
Pulmonary rehabilitation outcome
Time frame: At week 12 of pulmonary rehabilitation
Systemic multidimensional measurements （SMM） will be used to evaluate the outcomes of PR program, the patients will be grouped in very good, good, moderate and poor responders by cluster analysis. SMM are as follows: changes in the degree of dyspnea will be measured using the modified Medical Research Council scale; the St George's Respiratory Questionnaire will be use to evaluate changes in health status; exercise performance will be measured by a 6-min walk test and a constant work-rate test; the Canadian Occupational Performance Measure will be used to identify specific problematic activities of daily life; patients scored how well they were performing the problematic activities of daily life and how satisfied they were with this level of performance; symptoms of anxiety and depression will be measured by Hospital Anxiety and Depression Scale. The efficacy of the PR program of the whole sample will be evaluated based on the minimal clinically importance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Fei Wang principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Bronchiectasis, run by Peking University Third 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 11 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 18 Apr 2023. 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 Fei Wang, MD (0086 13671304203, 13671304203@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary rehabilitation outcome (time frame: At week 12 of pulmonary rehabilitation). 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 18 Apr 2023.