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NCT Number: NCT06798077

Chronic Airway Disease and Multimorbidity Cohort

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Respiratory Medicine, China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acute exacerbation during follow-up

    Time frame: From the date of discharge to 12 months post-discharge.

    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.

  2. All cause mortality

    Time frame: In-hospital and from enrollment to 12 months.

    All cause mortality.

  3. Quality of Life in COPD Patients

    Time frame: From enrollment to 12 months.

    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.

  4. Quality of Life in Asthma Patients

    Time frame: From enrollment to 12 months

    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.

  5. Quality of Life in Bronchiectasis Patients

    Time frame: From enrollment to 12 months.

    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.

  6. Lung Function

    Time frame: From enrollment to 12 months

    Assessment of lung function (FEV 1) over time.

  7. Healthcare Costs

    Time frame: In-hospital and from enrollment to 12 months.

    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).

  8. Adherence to Prescribed Medications and Treatments

    Time frame: From enrollment to 12 months.

    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).

  9. Polypharmacy Patterns

    Time frame: From enrollment to 12 months.

    Analysis of the prevalence and patterns of polypharmacy, defined as the use of 2 or more medications concurrently.

    Measurement Unit: Number of concurrent medications.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke Huang, MD.

CONTACT

[email protected]

+8615120079197

Wei Li, MD.

CONTACT

[email protected]

+8615910971249

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Collaborators

  • First Hospital of China Medical University
  • Henan Provincial People's Hospital
  • Ruijin Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Second Xiangya Hospital of Central South University
  • Sichuan University
  • Southern Medical University, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Chronic Airway Disease and Multimorbidity (CAM) Cohort: Protocol of a Prospective Multicenter Observational Cohort Study

Acronym: CAM Cohort

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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