Proteasis Evaluation in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Tours

Tours, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Kallikrein level in sputum by ELISA

Time frame: One sample at inclusion

Secondary outcomes

Comparison between kallikrein level and clinical or functionnal parameters

Time frame: All data will be identified at inclusion

Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Acronym: Pro-BPCO

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Oct 24, 2012
Registry last updated: Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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