Proteasis Evaluation in COPD (Pro-BPCO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01713335
First received: October 15, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Proteasis Evaluation in COPD

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Kallikrein level in sputum by ELISA [ Time Frame: One sample at inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison between kallikrein level and clinical or functionnal parameters [ Time Frame: All data will be identified at inclusion ] [ Designated as safety issue: No ]
    Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score


Biospecimen Retention:   Samples Without DNA

Sputum


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Stable COPD patients were recruited from pulmonary primary care of pulmonary division of CHRU of Tours.

COPD with acute exacerbation were recruited from hospitalisation of pulmonary division of CHRU of Tours and intensive care unit of CHRU of Tours.

Criteria

Inclusion Criteria for healthy subjects:

  • Smoker with tobacco consumption of 20 pack/year
  • Normal lung function tests

Exclusion Criteria for healthy subjects:

  • diagnosis of lung disease during the study
  • Asthma
  • Lung cancer
  • Pregnant and lactating women

Inclusion Criteria for stable COPD:

  • Smoker with tobacco consumption of 20 pack/year
  • FEV1/FVC<70% on lung function tests
  • no hospitalisation for exacerbation during 3 months before inclusion

Exclusion Criteria for stable COPD:

  • Asthma
  • Lung cancer
  • Pregnant and lactating women

Inclusion Criteria for COPD with exacerbation:

  • Smoker with tobacco consumption of 20 pack/year
  • worsening of pulmonary symptoms
  • FEV1/FVC<70% on lung function tests could be obtain before or 3 months after exacerbation

Exclusion Criteria for COPD with exacerbation:

  • Asthma
  • Lung cancer
  • Pregnant and lactating women
  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: NCT01713335

Contacts
Contact: Laurent Guilleminault, MD guillel@free.fr

Locations
France
CHRU Tours Recruiting
Tours, France
Contact: Laurent Guilleminault, MD       guillel@free.fr   
Principal Investigator: Laurent Guilleminault, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Laurent Guilleminault, MD Service de Pneumologie, CHRU Tours, Tours, France
Principal Investigator: Valérie Gissot, MD Centre d'Investigation Clinique, CHRU Tours, Tours, France
Principal Investigator: Antoine Guillon, MD Service de Réanimation médicale, CHRU Tours, Tours, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01713335     History of Changes
Other Study ID Numbers: C11-56, 2012-A00885-38
Study First Received: October 15, 2012
Last Updated: October 22, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on September 22, 2014