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Completed

NCT Number: NCT00448500

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 16, 2007
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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