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Not yet recruitingNCT06350305Updated Apr 11, 2024

Screening for High-risk Chronic Obstructive Pulmonary Disease

An observational study in High-risk COPD, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Henan University of Traditional Chinese Medicine · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
3,600
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD).

Read the detailed description

Targeting high-risk populations for chronic obstructive pulmonary disease (COPD), targeted at key issues such as unclear risk factors and lack of prevention and treatment plans, high-risk population screening was conducted to identify risk factors. This study is expected to detect at least 3600 high-risk individuals with early-stage chronic obstructive pulmonary disease. The incidence rate of high-risk individuals in the early stage of chronic obstructive pulmonary disease is 30%, which means the total screening population is 12000 cases.

02

Conditions studied

  • High-risk COPD

Keywords

  • high-risk COPD
  • scale
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 3,600 is above the median of 150 across 639 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Henan University of Traditional Chinese Medicine is the lead sponsor of 52 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

According to the Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (Revised in 2021), a multi-stage cluster random sampling method was used to select individuals from representative administrative villages with a history of chronic cough or sputum production, breathing difficulties, recurrent lower respiratory tract infections, and/or exposure to potential risk factors for chronic obstructive pulmonary disease.

Inclusion criteria

  • According to the Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (Revised in 2021), a multi-stage cluster random sampling method was used to select individuals from representative administrative villages with a history of chronic cough or sputum production, breathing difficulties, recurrent lower respiratory tract infections, and/or exposure to potential risk factors for chronic obstructive pulmonary disease.
  • The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Patients who are delirious, have impaired consciousness, dementia, various psychiatric disorders, etc., and cannot be accurately informed of their basic physical condition.
  • Patients who, in the opinion of the investigator, are not suitable for participation in this study.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
3,600 participants (estimated)
Patient registry
No

Interventions

  • Otherquestionnaire survey

    subjects fill out questionnaires

06

What researchers measure

Primary outcomes

  1. COPD screening questionnaire from Terrassa (EGARPOC)

    3-29 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥13, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  2. COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE)

    0-6 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥2, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  3. COPD Assessment Test (CAT)

    0-40 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was \>10, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  4. COPD screening questionnaire (COPD-Q)

    0-10 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥4, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  5. chronic obstructive pulmonary disease diagnostic questionnaire (CDQ)

    0-38 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥17, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  6. modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ)

    0-45 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥18, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  7. Simple screening questionnaire

    0-11 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥6, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  8. lung function questionnaire (LFQ)

    5-25 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≤18, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  9. chronic obstructive pulmonary disease screening questionnaire (COPD-SQ)

    0-38 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥16, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  10. chronic obstructive pulmonary disease population screener questionnaire (COPD-PS)

    0-10 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥5, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  11. Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS)

    0-9 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was ≥5, the participant needed to be seen by a physician for further testing to determine if they had COPD.

    Time frame: During screening

  12. Standardised Scale of Physical Fitness in Chinese Medicine

    Answer all the questions in the Classification and Determination of Physical Qualities in Chinese Medicine Table. Each question is rated on a 5-point scale, and the raw and transformed scores are calculated to determine the type of physical qualities according to the criteria. Raw score = sum of the scores of each entry. Transformation score = \[(raw score - number of entries)/(number of entries × 4)\] × 100.

    Time frame: During screening

  13. Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES)

    Subjects should fill in the relevant entries truthfully according to the category of symptoms as judged by the doctor and tick the appropriate box. Among them, the part of tongue and pulse should be filled in by the doctor.

    Time frame: During screening

07

Study locations

1 site
  • The First Affiliated Hospital of Henan University of Chinese Medicine
    Zhengzhou, Henan 450000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06350305
Lead sponsor
Henan University of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Apr 11, 2024

Study contacts

yang xie, doctor
Contact
xieyanghn@163.com
0371-66248624

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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