Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448500
Status:
COMPLETED
Last Update Posted:
2008-05-09
First Post:
2007-03-14
Brief Title:
Exhaled Breath Condensate EBC Assessment in Acute Exacerbation of Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Measurement of Biomarkers in the Exhaled Breath Condensate in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 manufacturers 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 0900 to 1000 on 2 consecutive days
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 manufacturers 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 0900 to 1000 on 2 consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None