Chronic Obstructive Pulmonary Disease (COPD)CAM CohortNCT06798077
Chronic Airway Disease and Multimorbidity Cohort
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by China-Japan Friendship Hospital at 9 sites in China.
Trial summary
Background: Chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma and bronchiectasis, are highly prevalent and cause serious disease burden. Multimorbidity is recognized to influence treatment decision and prognosis of patients with stable CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Bronchiectasis
- How many people
- 2,000 participants
- Where
- 9 sitesChina
- Study dates
- 1 Feb 2025to 31 Jul 2028
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The CAM cohort study focuses on hospitalized patients with chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma, and bronchiectasis, during acute exacerbation episodes. Participants are recruited from 9 medical centers across China, representing diverse geographic and clinical settings.
Who may be able to join
- Patients with chronic obstructive pulmonary disease ≥40 years of age; patients with asthma and bronchiectasis ≥18 years of age;
- The primary diagnosis on admission was "acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, or acute exacerbation of bronchiectasis".
Who cannot join
- Patients were unable to undergo spirometry during the stabilization period;
- Expected survival is less than 1 month;
- Refusal to sign an informed consent form;
- Chest imaging showed emerging patchy infiltrating shadows, lobar or segmental solid shadows, ground glass shadows, or interstitial changes with or without pleural effusion;
- Patients with cystic fibrosis or with interstitial lung disease or other lung diseases with tractional branchial dilatation.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
National Center for Respiratory Medicine, China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Ke Huang, MD, +86-15120079197, huangke_zryy@163.com
Ke Huang, MD
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Huihui Zeng, MD, +86-13637316849, bonemarrow@126.com
Yan Chen, MD, +86-13508471738, chenyan99727@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Diandian Li, MD, +86-13880541412, diandianl@163.com
Diandian Li, MD
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Xin Chen, MD, +86-13902205193, chen_xin1020@163.com
Xin Chen, MD
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200025
Wei Chen, MD, +86-13621715748, cw11242@rjh.com.cn
Wei Chen, MD
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Chenye Feng, MD, +86-13840012462, chenyef@163.com
Chenye Feng, MD
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Qiong Zhou, MD, +86-15994200188, zhouqiongtj@126.com
Qiong Zhou, MD
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710114
Ming Zhang, MD, +86-13259919643, zhangmingdr@163.com
Ming Zhang, MD
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Quncheng Zhang, MD, +86-15038142486, zhangqc@zzu.edu.cn
Quncheng Zhang, MD
About this study
Official title: Chronic Airway Disease and Multimorbidity (CAM) Cohort: Protocol of a Prospective Multicenter Observational Cohort Study
Background: Chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma and bronchiectasis, are highly prevalent and cause serious disease burden. Multimorbidity is recognized to influence treatment decision and prognosis of patients with stable CAD. The impact of multimorbidity on exacerbation CAD is under investigated.
Methods: The Chronic Airway Disease and Multimorbidity (CAM) cohort study is a prospective, multicenter, observational study aiming to recruit a minimum of 2000 patients hospitalized for exacerbation of COPD, asthma or bronchiectasis. Comprehensive data, including demographics, medical history, comorbidities, lung function, echocardiography, microbiological profiles, radiology, quality of life and treatment will be collected at baseline during the hospitalization. Follow-up data indicating the impact of both CAD and multimorbidity will be collected at 1-, 3-, 6-, 9- and 12-months after hospital discharge. Biospecimens, including blood and bronchoalveolar lavage fluid, will be collected and analyzed for biomarker detecting. Primary outcome are length of hospital stay and re-exacerbation during fellow-up. Secondary outcomes include comorbidity pattern and its impact on respiratory symptoms burden, quality of life, pulmonary function and chest imaging as well as cost and healthcare utilization.
Conclusions: The knowledge generated from CAM cohort study will fill crucial gaps in understanding how multimorbidity affects CAD and facilitate evidence-based clinical practice in the future.
Read the detailed description
The Chronic Airway Disease and Multimorbidity (CAM) Cohort is a nationwide, prospective, multicenter, longitudinal observational study aimed at understanding the epidemiology and impact of multimorbidity on patients hospitalized due to exacerbation of chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma, and bronchiectasis. The study will enroll 2,000 patients across 9 medical centers in China, following their health trajectory for one year post-hospitalization.
Objective The primary objective is to assess how multimorbidity influences treatment outcomes, hospitalization length, and readmission rates in CAD patients. Secondary goals include analyzing comorbidity patterns, their effects on symptom burden, quality of life, pulmonary function, healthcare costs, and utilization.
Study Design Participants meeting inclusion criteria will be recruited through hospital advertisements and professional referrals. Upon providing informed consent, demographic, clinical, and laboratory data will be recorded during baseline hospitalization. The study employs standardized questionnaires and clinical tools such as mMRC, CAT, and SGRQ for quality-of-life assessments. Specimens, including blood, bronchoalveolar lavage fluid (BALF), and sputum, will be collected and stored for biomarker analysis. Imaging studies such as chest CT and echocardiography will evaluate disease severity and cardiac function.
Patients will be systematically followed at 1, 3, 6, 9, and 12 months post-discharge to record disease progression, treatment adherence, exacerbations, and outcomes.
Data Collection Demographics and Risk Factors: Age, gender, smoking history, family history, and occupational exposures.
Symptoms: Disease-specific tools such as CAT/mMRC(COPD), ACQ-7 (asthma) and BEST (bronchiectasis) will quantify symptom severity.
Quality of Life (QoL): SGRQ for COPD, QoL-Bronchiectasis for bronchiectasis, and mini-AQLQ for asthma patients.
Laboratory Data: Arterial blood gas, blood count, liver and renal function, inflammatory markers, and allergy panels.
Muti-morbidities: Systematic documentation of pulmonary and extrapulmonary comorbidities, including their diagnosis, treatment, and severity.
Outcome Measures: The primary outcomes are hospital length of stay and re-exacerbation rates. Secondary outcomes include changes in pulmonary function, QoL, mental health indices, imaging findings, and healthcare resource utilization.
Quality Control Data will be managed using an electronic data capture(EDC) system, with built-in validation to ensure accuracy. Periodic data audits and centralized training for research coordinators will enhance data integrity. Monitoring committees will address data discrepancies promptly.
Ethics and Dissemination The protocol complies with the Declaration of Helsinki and has received approval from ethics committees of all participating centers. The findings will inform clinical guidelines, emphasizing the integration of multi-morbidity management in CAD care.
This study bridges significant knowledge gaps in CAD management, particularly concerning multimorbidity in hospitalized patients, aiming to enhance evidence-based clinical practices.
- Keywords
- multimorbidity, COPD, asthma, bronchiectasis, exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Bronchiectasis
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 |
|---|---|---|
| COPD group | Not described | |
| Asthma Group | Not described | |
| Bronchiectasis Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The length of time participants remain hospitalized from the date of admission to the date of discharge or death, whichever comes first.
Measured: From the date of admission until discharge or death, assessed over an estimated period of 3 to 30 days.
Secondary outcomes (9)
Acute exacerbation during follow-up
Exacerbations will be defined based on clinical criteria specific to each disease: increased respiratory symptoms requiring additional treatment.
Measurement Tools: The number of disease exacerbation.
Measured: From the date of discharge to 12 months post-discharge.
All cause mortality
All cause mortality.
Measured: In-hospital and from enrollment to 12 months.
Quality of Life in COPD Patients
Assessing quality of life in patients with COPD using validated tools. Measurement Tools: St. George's Respiratory Questionnaire (SGRQ), scores range from 0 to 100, with higher scores indicating worse quality of life.
Measured: From enrollment to 12 months.
Quality of Life in Asthma Patients
Assessing quality of life in patients with asthma using validated tools. Measurement tool: Mini Asthma Quality of Life Questionnaire (Mini-AQLQ), each question is scored from 1 to 7, with 15 questions and a total score of 105. The higher the score, the better the quality of life.
Measured: From enrollment to 12 months
Quality of Life in Bronchiectasis Patients
Assessing quality of life in patients with bronchiectasis using validated tools.
Measurement tool: Bronchiectasis Health Questionnaire (BHQ), each question is scored from 1 to 7, with 10 questions and a total score of 70. The higher the score, the better the quality of life.
Measured: From enrollment to 12 months.
Lung Function
Assessment of lung function (FEV 1) over time.
Measured: From enrollment to 12 months
Healthcare Costs
Evaluation of total healthcare costs related to the treatment of CAD, including direct costs such as hospitalisation, medication and outpatient costs.
Measurement Unit: Total cost in local currency (e.g., RMB).
Measured: In-hospital and from enrollment to 12 months.
Adherence to Prescribed Medications and Treatments
Evaluation of participants' adherence to prescribed medication regimens and treatments, using patient-reported adherence and prescription records.
Measurement Unit: Percentage of adherence (e.g., percentage of days covered).
Measured: From enrollment to 12 months.
Polypharmacy Patterns
Analysis of the prevalence and patterns of polypharmacy, defined as the use of 2 or more medications concurrently.
Measurement Unit: Number of concurrent medications.
Measured: From enrollment to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (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 Disease (COPD)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, First Hospital of China Medical University, Henan Provincial People's Hospital, Second Xiangya Hospital of Central South University, Sichuan University, Southern Medical University, China, Ruijin Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting Yang, MD, Principal investigator, China-Japan Friendship Hospital, National Center for Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798077
- Sponsor's protocol ID
- 2023ZD0506003
- Acronym
- CAM Cohort
- Status last verified
- Feb 2025
- First submitted
- 2 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The CAM cohort study has determined that individual participant data (IPD) will not be directly shared. Instead, supporting information and aggregated results will be made available in specific formats to ensure transparency while protecting participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Airway Disease and Multimorbidity (CAM) Cohort: Protocol of a Prospective Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06798077
- Acronym / sponsor ID
- CAM Cohort / 2023ZD0506003
- Keywords
- multimorbidity, COPD, asthma, bronchiectasis, exacerbation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, First Hospital of China Medical University, Henan Provincial People's Hospital, Second Xiangya Hospital of Central South University, Sichuan University, Southern Medical University, China, Ruijin Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jan 2025 (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.
Background: Chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma and bronchiectasis, are highly prevalent and cause serious disease burden. Multimorbidity is recognized to influence treatment decision and prognosis of patients with stable CAD. The impact of multimorbidity on exacerbation CAD is under investigated.
Methods: The Chronic Airway Disease and Multimorbidity (CAM) cohort study is a prospective, multicenter, observational study aiming to recruit a minimum of 2000 patients hospitalized for exacerbation of COPD, asthma or bronchiectasis. Comprehensive data, including demographics, medical history, comorbidities, lung function, echocardiography, microbiological profiles, radiology, quality of life and treatment will be collected at baseline during the hospitalization. Follow-up data indicating the impact of both CAD and multimorbidity will be collected at 1-, 3-, 6-, 9- and 12-months after hospital discharge. Biospecimens, including blood and bronchoalveolar lavage fluid, will be collected and analyzed for biomarker detecting. Primary outcome are length of hospital stay and re-exacerbation during fellow-up. Secondary outcomes include comorbidity pattern and its impact on respiratory symptoms burden, quality of life, pulmonary function and chest imaging as well as cost and healthcare utilization.
Conclusions: The knowledge generated from CAM cohort study will fill crucial gaps in understanding how multimorbidity affects CAD and facilitate evidence-based clinical practice in the future.
Detailed description
The Chronic Airway Disease and Multimorbidity (CAM) Cohort is a nationwide, prospective, multicenter, longitudinal observational study aimed at understanding the epidemiology and impact of multimorbidity on patients hospitalized due to exacerbation of chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma, and bronchiectasis. The study will enroll 2,000 patients across 9 medical centers in China, following their health trajectory for one year post-hospitalization.
Objective The primary objective is to assess how multimorbidity influences treatment outcomes, hospitalization length, and readmission rates in CAD patients. Secondary goals include analyzing comorbidity patterns, their effects on symptom burden, quality of life, pulmonary function, healthcare costs, and utilization.
Study Design Participants meeting inclusion criteria will be recruited through hospital advertisements and professional referrals. Upon providing informed consent, demographic, clinical, and laboratory data will be recorded during baseline hospitalization. The study employs standardized questionnaires and clinical tools such as mMRC, CAT, and SGRQ for quality-of-life assessments. Specimens, including blood, bronchoalveolar lavage fluid (BALF), and sputum, will be collected and stored for biomarker analysis. Imaging studies such as chest CT and echocardiography will evaluate disease severity and cardiac function.
Patients will be systematically followed at 1, 3, 6, 9, and 12 months post-discharge to record disease progression, treatment adherence, exacerbations, and outcomes.
Data Collection Demographics and Risk Factors: Age, gender, smoking history, family history, and occupational exposures.
Symptoms: Disease-specific tools such as CAT/mMRC(COPD), ACQ-7 (asthma) and BEST (bronchiectasis) will quantify symptom severity.
Quality of Life (QoL): SGRQ for COPD, QoL-Bronchiectasis for bronchiectasis, and mini-AQLQ for asthma patients.
Laboratory Data: Arterial blood gas, blood count, liver and renal function, inflammatory markers, and allergy panels.
Muti-morbidities: Systematic documentation of pulmonary and extrapulmonary comorbidities, including their diagnosis, treatment, and severity.
Outcome Measures: The primary outcomes are hospital length of stay and re-exacerbation rates. Secondary outcomes include changes in pulmonary function, QoL, mental health indices, imaging findings, and healthcare resource utilization.
Quality Control Data will be managed using an electronic data capture(EDC) system, with built-in validation to ensure accuracy. Periodic data audits and centralized training for research coordinators will enhance data integrity. Monitoring committees will address data discrepancies promptly.
Ethics and Dissemination The protocol complies with the Declaration of Helsinki and has received approval from ethics committees of all participating centers. The findings will inform clinical guidelines, emphasizing the integration of multi-morbidity management in CAD care.
This study bridges significant knowledge gaps in CAD management, particularly concerning multimorbidity in hospitalized patients, aiming to enhance evidence-based clinical practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | – |
| Asthma Group | – | – |
| Bronchiectasis Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CAM cohort study focuses on hospitalized patients with chronic airway diseases (CAD), including chronic obstructive pulmonary disease (COPD), asthma, and bronchiectasis, during acute exacerbation episodes. Participants are recruited from 9 medical centers across China, representing diverse geographic and clinical settings.
Key inclusion criteria (2 listed)
- Patients with chronic obstructive pulmonary disease ≥40 years of age; patients with asthma and bronchiectasis ≥18 years of age;
- The primary diagnosis on admission was "acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, or acute exacerbation of bronchiectasis".
Key exclusion criteria (5 listed)
- Patients were unable to undergo spirometry during the stabilization period;
- Expected survival is less than 1 month;
- Refusal to sign an informed consent form;
- Chest imaging showed emerging patchy infiltrating shadows, lobar or segmental solid shadows, ground glass shadows, or interstitial changes with or without pleural effusion;
- Patients with cystic fibrosis or with interstitial lung disease or other lung diseases with tractional branchial dilatation.
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
Length of hospital stay
Time frame: From the date of admission until discharge or death, assessed over an estimated period of 3 to 30 days.
The length of time participants remain hospitalized from the date of admission to the date of discharge or death, whichever comes first.
9 secondary outcomes
Acute exacerbation during follow-up
Time frame: From the date of discharge to 12 months post-discharge.
All cause mortality
Time frame: In-hospital and from enrollment to 12 months.
Quality of Life in COPD Patients
Time frame: From enrollment to 12 months.
Quality of Life in Asthma Patients
Time frame: From enrollment to 12 months
Quality of Life in Bronchiectasis Patients
Time frame: From enrollment to 12 months.
Lung Function
Time frame: From enrollment to 12 months
Healthcare Costs
Time frame: In-hospital and from enrollment to 12 months.
Adherence to Prescribed Medications and Treatments
Time frame: From enrollment to 12 months.
Polypharmacy Patterns
Time frame: From enrollment to 12 months.
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 17 Feb 2025.
- Individual participant dataSharing planned: No. The CAM cohort study has determined that individual participant data (IPD) will not be directly shared. Instead, supporting information and aggregated results will be made available in specific formats to ensure transparency while protecting participant privacy.
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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.
Ting Yang, MD principal investigator
China-Japan Friendship Hospital, National Center for Respiratory Medicine
9 sites 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 (COPD) and Asthma, run by China-Japan Friendship Hospital at 9 sites 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 5 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Ke Huang, MD. (+8615120079197, huangke_zryy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From the date of admission until discharge or death, assessed over an estimated period of 3 to 30 days.). 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 17 Feb 2025.