- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448500
Exhaled Breath Condensate (EBC) Assessment in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Measurement of Biomarkers in the Exhaled Breath Condensate in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fanny WS Ko, MBChB, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resp/ko/2006/004
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