COPDNCT03187236
Registry for Chronic Obstructive Pulmonary Disease With Anxiety and Depression in China
An observational study of COPD and Anxiety, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- COPD, Anxiety, Depression
- How many people
- 1,906 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- How long will I take part?
- 3 Years
- 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 Up to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Stable COPD patients
Who may be able to join
- Stable chronic obstructive pulmonary disease (COPD) patients
Who cannot join
- Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
- Patients with tumor history during past 5 years
- Patients with COPD exacerbations during past 4 weeks
- Participants in clinical trials
- Patients in pregnancy or breastfeeding
- Patients unable to complete questionaire independently
- Patients older than 80 years old
- Patients receiving long-term domiciliary oxygen therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Jiangna Han, MD, 13520053104, 13520053104@139.com
About this study
Official title: The Early Detection, Clinical Course and Prognosis of Anxiety and Depression in Chronic Obstructive Pulmonary Disease
Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. The study aim to investigate the prevalence and long-term outcome of anxiety and depression in COPD.
- Conditions
- COPD, Anxiety, Depression
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
moderate and severe COPD exacerbations
total times
Measured: 3 years
Secondary outcomes (1)
All-cause mortality
mortality in %
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017 (estimated)
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,906 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187236
- Sponsor's protocol ID
- 2016YFC1304404A
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu D, Long B, Huang B, Zhong X, Chen X, Shen X, Huang Q, Zhang W, Wu J, Chen M, Li D, Wu B, Lv D, Huang D, Zhao X. Exploring the Relationship Between Education, Living Environment, and Anxiety/Depression Among Stable Patients: Insights from the COPD-AD China Registry Study. Int J Chron Obstruct Pulmon Dis. 2024 Sep 23;19:2063-2071. doi: 10.2147/COPD.S455923. eCollection 2024.
PubMed 39346627Zhao X, Su R, Hu R, Chen Y, Xu X, Yuan Y, Zhang J, Zhang W, Yang Y, Chen M, Li D, Wu B, Huang D, Wu D. Sarcopenia index as a predictor of clinical outcomes among older adult patients with acute exacerbation of chronic obstructive pulmonary disease: a cross-sectional study. BMC Geriatr. 2023 Feb 11;23(1):89. doi: 10.1186/s12877-023-03784-7.
PubMed 36774462
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Detection, Clinical Course and Prognosis of Anxiety and Depression in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03187236
- Acronym / sponsor ID
- 2016YFC1304404A
- Conditions
- COPD, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,906 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (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.
Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. The study aim to investigate the prevalence and long-term outcome of anxiety and depression in COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Stable COPD patients
Key inclusion criteria (1 listed)
- Stable chronic obstructive pulmonary disease (COPD) patients
Key exclusion criteria (8 listed)
- Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
- Patients with tumor history during past 5 years
- Patients with COPD exacerbations during past 4 weeks
- Participants in clinical trials
- Patients in pregnancy or breastfeeding
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
moderate and severe COPD exacerbations
Time frame: 3 years
total times
1 secondary outcome
All-cause mortality
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 39346627Wu D, Long B, Huang B, Zhong X, Chen X, Shen X, Huang Q, Zhang W, Wu J, Chen M, Li D, Wu B, Lv D, Huang D, Zhao X. Exploring the Relationship Between Education, Living Environment, and Anxiety/Depression Among Stable Patients: Insights from the COPD-AD China Registry Study. Int J Chron Obstruct Pulmon Dis. 2024 Sep 23;19:2063-2071. doi: 10.2147/COPD.S455923. eCollection 2024.
- Derived from this study: PubMed 36774462Zhao X, Su R, Hu R, Chen Y, Xu X, Yuan Y, Zhang J, Zhang W, Yang Y, Chen M, Li D, Wu B, Huang D, Wu D. Sarcopenia index as a predictor of clinical outcomes among older adult patients with acute exacerbation of chronic obstructive pulmonary disease: a cross-sectional study. BMC Geriatr. 2023 Feb 11;23(1):89. doi: 10.1186/s12877-023-03784-7.
- 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.
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 COPD and Anxiety, run by Chinese Academy of Medical Sciences, Fuwai 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 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. 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 Jiangna Han, MD (13520053104, 13520053104@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
moderate and severe COPD exacerbations (time frame: 3 years). 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 NCT03187236, 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 14 Jun 2017.