Chronic Obstructive Pulmonary DiseaseNCT03450603
Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2017to 30 Dec 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects aged >40 years,baseline post-bronchodilator FEV1 less than 80% of the reference value and FEV1/FVC of less than or equal to 0.7, when clinically stable or Exacerbation; current,ex-smokers or no smokers. Exclusion Criteria：Participants had COPD complicated by a comorbidity such as pneumothorax, pulmonary embolism, lung cancer, or left cardiac insufficiency. Other exclusion criteria included a diagnosis of asthma, extensive bronchiectasis, sequelae of tuberculosis, interstitial lung disease, or restrictive disease.
Who may be able to join
- Clinical diagnosis of Chronic obstructive pulmonary disease
- aged >= 40 years
Who cannot join
- spirometry can not be completed because of various reasons
- asthma
- pulmonary embolism
- lung cancer
- sequelae of tuberculosis
- extensive bronchiectasis
- interstitial lung disease
- left cardiac insufficiency
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
Department of Respiratory Medicine, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Yue Zhang, +86-21-25077373, zhangyue01@xinhuamed.com.cn
About this study
Official title: It is Crucial to Identify Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease in Order to Provide Adequate Intensive Therapy and Closer Follow-up
Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health care utilisation and costs. However, the severity,evolution and outcome of an exacerbation may differ significantly between patients - some patients will recover completely in a short period of time while others may die. The identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.The pathogenesis of COPD is still unclear, so there is no specific treatment at present .COPD was considered to be the result of a combination of environmental and genetic factors. Genetic factors play an important role in the acute exacerbation of COPD.Therefore, it is an urgent need to explore the heterogeneity of COPD phenotype from the perspective of genes and to seek individualized prevention and treatment programs.This study is intended to provide a theoretical basis for the prevention, evaluation and development of individualized treatment plans for acute exacerbation of COPD, thereby improving the prognosis of the disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| stable COPD | Chronic obstructive pulmonary disease (COPD) was confirmed if the patient had a baseline post-bronchodilator FEV1 less than 80% of the reference value and forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) quotient of less than 70%.Select patients with COPD without acute attack within three months． | |
| exacerbation of COPD | Exacerbation was defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that was beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with acute exacerbations of chronic obstructive pulmonary disease
Acute exacerbations of chronic obstructive pulmonary disease is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start10 Dec 2017
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (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 Xinhua Hospital, Shanghai Jiao Tong 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450603
- Sponsor's protocol ID
- XH-17-019
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2018
- Last updated
- 11 Mar 2026
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- It is Crucial to Identify Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease in Order to Provide Adequate Intensive Therapy and Closer Follow-up
- ClinicalTrials.gov ID
- NCT03450603
- Acronym / sponsor ID
- XH-17-019
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Mar 2018 (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.
Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health care utilisation and costs. However, the severity,evolution and outcome of an exacerbation may differ significantly between patients - some patients will recover completely in a short period of time while others may die. The identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.The pathogenesis of COPD is still unclear, so there is no specific treatment at present .COPD was considered to be the result of a combination of environmental and genetic factors. Genetic factors play an important role in the acute exacerbation of COPD.Therefore, it is an urgent need to explore the heterogeneity of COPD phenotype from the perspective of genes and to seek individualized prevention and treatment programs.This study is intended to provide a theoretical basis for the prevention, evaluation and development of individualized treatment plans for acute exacerbation of COPD, thereby improving the prognosis of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable COPD | – | –Chronic obstructive pulmonary disease (COPD) was confirmed if the patient had a baseline post-bronchodilator FEV1 less than 80% of the reference value and forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) quotient of less than 70%.Select patients with COPD without acute attack within three months． |
| exacerbation of COPD | – | –Exacerbation was defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that was beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects aged >40 years,baseline post-bronchodilator FEV1 less than 80% of the reference value and FEV1/FVC of less than or equal to 0.7, when clinically stable or Exacerbation; current,ex-smokers or no smokers. Exclusion Criteria：Participants had COPD complicated by a comorbidity such as pneumothorax, pulmonary embolism, lung cancer, or left cardiac insufficiency. Other exclusion criteria included a diagnosis of asthma, extensive bronchiectasis, sequelae of tuberculosis, interstitial lung disease, or restrictive disease.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Chronic obstructive pulmonary disease
- aged >= 40 years
Key exclusion criteria (8 listed)
- spirometry can not be completed because of various reasons
- asthma
- pulmonary embolism
- lung cancer
- sequelae of tuberculosis
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
Number of participants with acute exacerbations of chronic obstructive pulmonary disease
Time frame: one year
Acute exacerbations of chronic obstructive pulmonary disease is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD.
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 11 Mar 2026.
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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 Chronic Obstructive Pulmonary Disease, run by Xinhua Hospital, Shanghai Jiao Tong 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 2 inclusion and 8 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 11 Mar 2026. 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 Yue Zhang (+86-21-25077373, zhangyue01@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute exacerbations of chronic obstructive pulmonary disease (time frame: one year). 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 11 Mar 2026.