Clinical trial NCT06798077: Chronic Airway Disease and Multimorbidity Cohort
Official title: Chronic Airway Disease and Multimorbidity (CAM) Cohort: Protocol of a Prospective Multicenter Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Bronchiectasis
Keywords: multimorbidity
COPD
asthma
bronchiectasis
exacerbation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
name: First Hospital of China Medical University
name: Henan Provincial People's Hospital
name: Second Xiangya Hospital of Central South University
name: Sichuan University
name: Southern Medical University, China
name: Ruijin Hospital
name: Wuhan Union Hospital, China
First posted: 2025-01-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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".

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Length of hospital stay
timeFrame: From the date of admission until discharge or death, assessed over an estimated period of 3 to 30 days.
Secondary outcomes:
measure: Acute exacerbation during follow-up
timeFrame: From the date of discharge to 12 months post-discharge.
measure: All cause mortality
timeFrame: In-hospital and from enrollment to 12 months.
measure: Quality of Life in COPD Patients
timeFrame: From enrollment to 12 months.
measure: Quality of Life in Asthma Patients
timeFrame: From enrollment to 12 months
measure: Quality of Life in Bronchiectasis Patients
timeFrame: From enrollment to 12 months.
measure: Lung Function
timeFrame: From enrollment to 12 months
measure: Healthcare Costs
timeFrame: In-hospital and from enrollment to 12 months.
measure: Adherence to Prescribed Medications and Treatments
timeFrame: From enrollment to 12 months.
measure: Polypharmacy Patterns
timeFrame: From enrollment to 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Respiratory Medicine, China-Japan Friendship Hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: China-Japan Friendship Hospital, National Center for Respiratory Medicine
name: Ting Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: