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NCT01713335 Clinical Trial

Proteasis Evaluation in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— Pro-BPCO  

Official title:
Proteasis Evaluation in COPD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01713335
Other study ID # C11-56
Secondary ID 2012-A00885-38
Status Completed
Phase
First received
Last updated
Start date October 18, 2012
Est. completion date April 2017

Study information
Verified date August 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kallikrein level in sputum by ELISA One sample at inclusion
Secondary Comparison between kallikrein level and clinical or functionnal parameters Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score All data will be identified at inclusion
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