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

This study has been completed.
Sponsor:
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00883701
First received: April 16, 2009
Last updated: April 28, 2010
Last verified: August 2009
  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 and that these changes are more pronounced in COPD patients than in subjects without COPD who undergo respiratory infection.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Granzymes and Perforin at the Onset of COPD Exacerbations

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Expression of granzymes and perforin in neutrophiles and LGL sputum cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

sputum cells and supernatant


Estimated Enrollment: 30
Study Start Date: December 2002
Study Completion Date: September 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD patients
COPD patients who undergo exacerbation
Non COPD patients (controls)
Subjects who undergo respiratory infection (acute bronchitis) without COPD or other respiratory illness

  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

COPD patients

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

Control subjects

Subjects who seek medical assistance for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough) are recruited from a community based outpatient primary medical clinic by consecutive sampling.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Greece
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: Stelios Lazarou, University of Thessaly
ClinicalTrials.gov Identifier: NCT00883701     History of Changes
Other Study ID Numbers: SL19021970DM
Study First Received: April 16, 2009
Last Updated: April 28, 2010
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Thessaly:
Chronic Obstructive Pulmonary Disease
exacerbations
perforin
granzymes

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014