Proteasis Evaluation in COPD | NCT01713335

Studies
Proteasis Evaluation in COPD

NCT01713335

Sponsor

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

Status

Completed

Last Update Posted

Aug 26, 2021Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A00885-38	Registry Identifier	IDRCB

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2012Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 22, 2012

First Posted Date

Oct 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2021

Last Update Posted Date

Aug 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

134Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kallikrein level in sputum by ELISA		One sample at inclusion

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Tours		Tours			France

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided