Infectious Etiology of Acute Exacerbations of COPD

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00441389
First received: February 27, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Longitudinal
Official Title: Infectious Etiology of Acute Exacerbations of COPD in Hong Kong

Further study details as provided by Chinese University of Hong Kong:

Estimated Enrollment: 500
Study Start Date: May 2004
Estimated Study Completion Date: December 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441389

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Fanny KO, FCCP Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00441389     History of Changes
Other Study ID Numbers: Resp/ko/2006/003
Study First Received: February 27, 2007
Last Updated: February 27, 2007
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Bacteria
Viruses
COPD
infectious etiology for acute exacerbation of COPD

Additional relevant MeSH terms:
Communicable Diseases
Infection
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014