A Prospective Study Readmission and Mortality of COPD Patients

NCT02815761 | Recruiting

• 1 other identifier: COPD readmssion_2011a
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a common disease worldwide with a high burden on healthcare resources. The prevalence of COPD varied from 11.4 to 26.1% according to a recent multi-city population study using spirometry. In Hong Kong (HK), the prevalence rates of COPD in the elderly population aged ≥60 years were 25.9% and 12.4% based on the spirometric definition of forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC) ratio \<70% and the lower limit of normal of the FEV1/FVC respectively. In 2005, the crude mortality rate of COPD was 29.1/100 000, while the crude hospitalization rate was 193/100,000 in HK. In HK, COPD ranked second as a respiratory cause for hospitalization. In those 75 years or older, the hospitalization rate for COPD was as high as 2,225/100,000. The economic burden of COPD on the society is enormous. Previous studies gave information on the overall morbidity, mortality and the prevalence of COPD in HK. One study compared the management of COPD patients in HK with other countries and found that COPD patients in HK were under-treated. No large scale study has looked into the details of COPD patients in HK, like their co-morbidities and how they are being treated and how these factors affect the readmission of these patients. Large prospective studies which incorporate all the potentially relevant variables are required to refine prediction of the important outcomes of AECOPD and thus to inform clinical decision making, for example on escalation of care, facilitated discharge and provision of palliative care.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• COPD exacerbations

  Exacerbations that required treatment with antibiotic or systemic steroid

  3 years

• Mortality

  death

  3 years

Interventions

NO intervention, just observation OTHER

No intervention.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective observational study of patients. Patients who are admitted to the participating hospital with acute exacerbations of COPD (AECOPD) will be recruited. AECOPD was defined as occurring when a patient with background COPD11, with FEV1/FVC ratio \<70%, presented with at least two major symptoms (increased dyspnea, increased sputum purulence, or increased sputum volume), or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, or cough) for at least 2 consecutive days.

You may qualify if:

• Subjects with a diagnosis of COPD according to the Global Initiative for chronic Obstructive Lung Disease (GOLD) Guideline16 with previous spirometry showing FEV1/FVC ratio of \<0.70 with an AECOPD will be recruited for this study.
• Age ≥40 years

You may not qualify if:

• Subjects who have been diagnosed with asthma, bronchiectasis or other chronic lung disease apart from COPD will be excluded
• Patients with history of lung resection
• \. Those who are unable to give consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Ko FWS, Chan KP, Ngai J, Ng SS, Yip WH, Ip A, Chan TO, Hui DSC. Blood eosinophil count as a predictor of hospital length of stay in COPD exacerbations. Respirology. 2020 Mar;25(3):259-266. doi: 10.1111/resp.13660. Epub 2019 Aug 6.

  PMID: 31385389 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken at first visit for assessment of inflammatory markers.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fanny Ko, MD

  fannyko@cuhk.edu.hk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny Ko, MD

CONTACT

fannyko@cuhk.edu.hk

David Hui, MD

CONTACT

dschui@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

HK (1)