Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02815761 |
| Other study ID # |
COPD readmssion_2011a |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
Fanny Ko, MD |
| Email |
fannyko[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Aim of this study
The aim of this study is to assess the factors that are related to readmission and mortality
of COPD patients in Hong Kong.
Method
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. Written informed consent will
be obtained from each subject.
Inclusion criteria:
1. 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.
2. Age ≥40 years
Exclusion criteria:
1. Subjects who have been diagnosed with asthma, bronchiectasis or other chronic lung
disease apart from COPD will be excluded
2. Patients with history of lung resection
4. Those who are unable to give consent Baseline assessments
1. Baseline assessments will be performed at 6-8 weeks after the AECOPD when the patients
are at their stable state.
2. Demographic data including age, sex, body weight, height, smoking history, social
history and medication usage, co-morbidities and any home oxygen or non-invasive
positive pressure ventilation (NPPV) usage will be collected. Number of hospitalizations
and accident and emergency department attendance in the past 12 month will be recorded.
Any history of intubation or acute NPPV usage will be noted also.
3. American Thoracic Society (ATS) respiratory questionnaire17 will be asked.
4. Spirometry will be performed using the MICROLAB 3300 spirometer (Micro Medical, Kent,
UK) in a sitting position, according to the ATS/European Respiratory Society (ERS)
standards.18 Both pre- and post-bronchodilator (20 min after inhaling 400 mg of
salbultamol [Ventolin; GlaxoSmithKline, E´ vreux, France] through a 500 mL spacer) tests
will be performed. The updated predicted spirometric values for the Hong Kong Chinese
were used.
5. Six min walk test will be performed according to the ATS guideline.
6. Modified Medical Research Council dyspnoea scale (MMRC)21 will be assessed.
7. St George's Respiratory Questionnaire (SGRQ)22 and medical outcomes short form 36
questionnaire (SF-36) 23 will be administered to all subjects.
8. Depression score
9. Blood saved for inflammatory markers analyses
Subsequent assessment:
Subjects will be reassessed every 12 months for repeat spirometry, 6 minute walk test, MMRC,
SGRQ and SF-36 score for a total of 3 years. All hospitalizations, scheduled and unscheduled
clinic visits in the subsequent 36 months after the baseline assessment will be recorded by
asking the patient and with verification of their computer medical records. Any mortality
(and the cause) will also be recorded.
Sample size:
This is a prospective observational study with primary aim to assess factors related to
readmission and mortality of COPD patients in Hong Kong. We believe a sample size of 800
would be able to give us some meaningful data.
Data analysis:
Data will be analyzed by the Statistical Package of the Social Science (SPSS) Statistical
software for Window, Version 17.0 (SPSS Inc, IL, USA). Descriptive statistics will be used
and data will be presented as mean (SD) or median (IQR) as appropriate. Chi-square test,
t-test, Mann-Whitney U test will be used to compare the clinical parameters of COPD patients
with the different disease severities as appropriate. A p value of < 0.05 will be considered
to be significant.
