Granzymes and Perforin at the Onset of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

This study has been completed.

First Received: April 16, 2009 Last Updated: April 20, 2009 History of Changes

Sponsored by:	University of Thessaly
Information provided by:	University of Thessaly
ClinicalTrials.gov Identifier:	NCT00883701

Purpose

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.

Condition
Chronic Obstructive Pulmonary Disease

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Granzymes and Perforin at the Onset of COPD Exacerbations

Further study details as provided by University of Thessaly:

Primary Outcome Measures:

Expression of granzymes and perforin in neutrophiles and LGL sputum cells [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

sputum cells and supernatant

Enrollment:	20
Study Start Date:	December 2002
Study Completion Date:	April 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects with COPD Subjects are recruited from a community based outpatient primary medical clinic by consecutive sampling.

Criteria

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

Exclusion Criteria:

Patients with Asthma or other respiratory disease were excluded from this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883701

Locations

Greece, Thessaly
University Hospital Larisa
Larisa, Thessaly, Greece

Sponsors and Collaborators

University of Thessaly

Investigators

Study Director:

Demos Makris, MD

University of Thessaly

More Information

No publications provided

Responsible Party:	University of Thessaly ( Stelios Lazarou )
Study ID Numbers:	SL19021970DM
Study First Received:	April 16, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00883701 History of Changes
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by University of Thessaly:

Chronic Obstructive Pulmonary Disease
exacerbations
perforin
granzymes

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 06, 2009