Exhaled Breath Condensate (EBC) Assessment in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

May 6, 2008 updated by: Chinese University of Hong Kong

Measurement of Biomarkers in the Exhaled Breath Condensate in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

This study aimed to assess airway inflammation in patients during the course of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) by serial analyses of their exhaled breath condensates (EBC).

Study Overview

Status

Completed

Detailed Description

Subject recruitment

Patients who had been admitted to the Prince of Wales Hospital with AECOPD were recruited for this study. Subjects with pneumonic changes on the chest radiographs were excluded. Age and sex-matched COPD subjects at stable state (without AECOPD for at least 10 weeks) and healthy, non-smoking subjects were recruited as controls.

Collection of exhaled breath condensate (EBC) EBC was collected using the EcoScreen (VIASYS Healthcare, Conshohochen, PA, USA) according to the manufacturer's instructions. EBC was stored in 250 microL aliquots immediately at -70oC until analysis. EBC was collected on Day 5, 14, 30 and 60 after hospitalization for subjects with AECOPD. For the stable COPD patients and normal controls, EBC collection was performed once.

Measurement of TNF alpha, LTB4 and IL-8 The concentrations of TNF alpha, LTB4, and IL-8 in EBC were measured in one batch by high-sensitivity sandwich enzyme immunoassays (TNF alpha and IL-8 from BioSource International, Camarillo, CA, USA; LTB4 from Cayman Chemical Company, Ann Arbor, MI, USA) according to the manufacturers' instructions. Intra-subject repeatability of TNF alpha, LTB4 and IL-8 was assessed by collection of EBC in stable COPD subjects. EBC was collected as described above at the same time (09:00 to 10:00) on 2 consecutive days.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients with exacerbations Stable COPD patients Normal subjects

Description

Inclusion Criteria:

  • Patients who had been admitted to the Prince of Wales Hospital with AECOPD were recruited for this study. AECOPD was defined when a patient with background COPD according to the GOLD guideline presented with at least two of the following major symptoms (increased dyspnoea, increased sputum purulence, increased sputum volume) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.
  • Age and sex-matched COPD subjects at stable state (without AECOPD for at least 10 weeks) and healthy, non-smoking subjects were recruited as controls. Current smokers (defined as cigarette smoking in the last 6 months) were excluded from this study.

Exclusion Criteria:

  • Subjects with pneumonic changes on the chest radiographs were excluded.
  • Current smokers (defined as cigarette smoking in the last 6 months) were excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fanny WS Ko, MBChB, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

March 14, 2007

First Posted (Estimate)

March 16, 2007

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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