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Pro-BPCO: Proteasis Evaluation in COPD

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT01713335
Collaborator
(none)
134
Enrollment
1
Location
53.4
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    134 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Proteasis Evaluation in COPD
    Actual Study Start Date :
    Oct 18, 2012
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Kallikrein level in sputum by ELISA [One sample at inclusion]

    Secondary Outcome Measures

    1. Comparison between kallikrein level and clinical or functionnal parameters [All data will be identified at inclusion]

      Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 CHRU Tours Tours France

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT01713335
    Other Study ID Numbers:
    • C11-56
    • 2012-A00885-38
    First Posted:
    Oct 24, 2012
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Aug 26, 2021