Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Granzymes and Perforin at the Onset of COPD Exacerbations
Verified date | August 2009 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Observational |
COPD exacerbations are characterized by an excessive accumulation and activation of
inflammatory cells in the airways. It is not known whether this phenomenon represents a risk
for for lung damage via the release in the extracellular environment of potent cytolitic
cellular granular contents such as granzymes and perforin.
The investigators assess the intracellular expression of granzymes and perforin in
neutrophils and large granular lymphocytes (LGL) at the onset of exacerbations compared to
stable disease.
The investigators hypothesize that a greater release of intracellular perforin and granzymes
from neutrophils and LGL into the extracellular environment occur at exacerbations compared
to stable condition and that these changes are more pronounced in COPD patients than in
subjects without COPD who undergo respiratory infection.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2009 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
COPD patients Inclusion Criteria: - All COPD patients who seek medical assistance at the clinic during the study period will be asked about COPD exacerbation related symptoms-medical history and then they will be included in the study if they satisfied all the following criteria: - COPD diagnosis according to the GOLD Consensus Statement - initiation of symptoms diagnostic for COPD exacerbation in the past 72 hours - abstention from any new therapeutic intervention - absence of any signs suggestive of severe exacerbation requiring hospitalization Control subjects Inclusion Criteria: - Subjects who seek medical assistance at respiratory clinic for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough) - medical history free of COPD, Asthma, pneumonia, other chronic respiratory disease or congestive cardiac failure, - initiation of symptoms in the past 72 hours, - abstention from any new therapeutic intervention, and - absence of any signs suggestive of clinical condition requiring hospitalization. Exclusion Criteria: - Patients with Asthma or other respiratory disease will be excluded from this study |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital Larisa | Larisa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression of granzymes and perforin in neutrophiles and LGL sputum cells | 6 months | No |
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