Proteasis Evaluation in COPD

NCT01713335 | Completed

• 2 other identifiers: C11-562012-A00885-38
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Kallikrein level in sputum by ELISA

  One sample at inclusion

Secondary Outcomes (1)

• Comparison between kallikrein level and clinical or functionnal parameters

  All data will be identified at inclusion

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• diagnosis of lung disease during the study
• Asthma
• Lung cancer
• Pregnant and lactating women
• Smoker with tobacco consumption of 20 pack/year
• FEV1/FVC\<70% on lung function tests
• Asthma
• Lung cancer
• Pregnant and lactating women
• 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
• Asthma
• Lung cancer
• Pregnant and lactating women

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CHRU Tours

Tours, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 24, 2012
• Study Start: October 18, 2012
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

FR (1)