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Chronic Obstructive Pulmonary DiseaseNCT00441389

Infectious Etiology of Acute Exacerbations of COPD

An observational study of Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the infectious etiology related to acute exacerbation of COPD in Hong Kong Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
How many people
500 participants
Where
No sites listed yet
Study dates
May 2004to Dec 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Infectious Etiology of Acute Exacerbations of COPD in Hong Kong

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

Read the 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.

Keywords
Bacteria, Viruses, COPD, infectious etiology for acute exacerbation of COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Virus Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2007 (estimated)
  2. Study startMay 2004
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Natural history
Time perspective
Prospective
Enrolment
500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00441389
Sponsor's protocol ID
Resp/ko/2006/003
Status last verified
Feb 2007
First submitted
27 Feb 2007
Last updated
28 Feb 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2007.

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