Infectious Etiology of Acute Exacerbations of COPD

NCT ID: NCT00441389

Last Updated: 2007-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-12-31

Brief Summary

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To assess the infectious etiology related to acute exacerbation of COPD in Hong Kong

Detailed Description

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Subject recruitment

Patients admitted with AECOPD will be recruited for this study. AECOPD is defined a patient with background COPD with at least two of the major symptoms (increased dyspnoea, increased sputum purulence, increased sputum amount) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days. Informed written consent will be obtained. Exclusion criteria included patients with myocardial infarction within the preceding 6 months, unstable angina, congestive heart failure (with New York Heart Association class III or IV) and those who cannot give consent for the study.

Demographic data and management in hospital Detailed information on the COPD exacerbations including demographic data (age, sex, height and weight, background illness and functional status), symptoms, blood test results and length of hospital stay will be recorded. In addition, chest radiographs will be assessed by the investigators (respiratory physicians) and abnormalities like pneumonic changes will be noted. The type and duration of antibiotics used will be recorded. Any non-invasive ventilation used or intensive care unit admissions will be assessed.

Microbiological test Routine and mycobacterial sputum culture, nasopharyngeal aspirate for viruses, blood for atypical pneumonia serology and urine for pneumococcal and legionella species will be collected and processed by standard microbiological techniques in the microbiology laboratory of the Prince of Wales Hospital for each patient upon admission to medical wards. Convalescent atypical pneumonia serology will be collected 14 days later. The sensitivity of the cultured organisms to antibiotics will also be assessed.

Follow up of progress of patients post discharge During follow up, lung function (including spirmotery pre and post bronchodilator and 6 minutes walk test) of the patient will be monitored at 1 month post discharge and subsequently at 6 months interval. The degree of dyspnoea will be assessed by modified Medical Research Council dyspnoea scale (MMRC) and quality of life will be assessed by St George's Respiratory Questionnaire (SGRQ) at 1 month and 12 months post discharge. Patients will be followed up in the lung function laboratory for 2 year (at 1 month, 6 months, 12 months, 18 months and 24 months). The patient and the family will be contacted if the patient failed to return for appointments. Death from any cause and from special respiratory causes will be recorded. Cause of death will be reviewed by the investigators by reviewing the medical record and death certificate.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Bacteria Viruses COPD infectious etiology for acute exacerbation of COPD

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients admitted with AECOPD will be recruited for this study.
* AECOPD is defined a patient with background COPD16 with at least two of the major symptoms (increased dyspnoea, increased sputum purulence, increased sputum amount) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.
* Informed written consent will be obtained.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Fanny KO, FCCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Other Identifiers

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Resp/ko/2006/003

Identifier Type: -

Identifier Source: org_study_id