Development of a Noninvasive Method of Evaluation of Pulm... | NCT00356629

Studies
Development of a Noninvasive Method of Evaluation of Pulmonary Inflammation in the Condensates of Exhaled Air

NCT00356629

Sponsor

University Hospital, Tours

Status

Terminated

Last Update Posted

Nov 14, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Bronchopulmonary Ignition
Condensate of Exhaled Air
Mucoviscidosis
Asthma

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

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Technical problem

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Jul 2008Estimated

First Submitted Date

Jul 25, 2006

First Submission Date that Met QC Criteria

Jul 25, 2006

First Posted Date

Jul 26, 2006Estimated

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

Nov 13, 2008

Last Update Posted Date

Nov 14, 2008Estimated

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 the study is identify biological parameters reflecting proteolytic activity in the exhaled condenstaes which might be useful to follow up pulmonary inflammation in various conditions including cystic fibrosis, COPD, asthma, tobacco exposure. Three proteases will be analyzed, i.e. elastase, proteinase 3 and cathepsin G. Results in the condensates will be compared to those obtained in sputum.

Detailed Description

5 groups of 20 individuals each: group 1 CF, group 2 COPD, group 3 asthma, group 4 tobacco exposure, group 5 control subjects.

Collection of exhaled condensates in all subjects and of sputum in subjects belonging to groups 1 and 2.

Clinical examination and PFTs in all patients.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

Eligibility Criteria

Inclusion criteria

Subjects suffering from CF, COPD, asthma and tobacco exposure (groups 1 to 4) and controls (group 5)
aged more or equal to 18
stable disease
able to perform PFTs
informed consent signed
affiliated to french social insurance

Exclusion Criteria:

acute exacerbation of the disease during the last 2 weeks
IV or oral steroids or antibiotics during the last 2 weeks
hospitalization during the last 2 weeks
colonization by S aureus methicillin resistant and/or Burkholderia cepacia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ubjects suffering from CF, COPD, asthma and tobacco exposure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DIOT Patrice, Pr	service de Pneumologie et EFR CHRU Tours	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pneumologie et EFR CHRU Tours		Tours		37044	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16627747	Background	Attucci S, Gauthier A, Korkmaz B, Delepine P, Martino MF, Saudubray F, Diot P, Gauthier F. EPI-hNE4, a proteolysis-resistant inhibitor of human neutrophil elastase and potential anti-inflammatory drug for treating cystic fibrosis. J Pharmacol Exp Ther. 2006 Aug;318(2):803-9. doi: 10.1124/jpet.106.103440. Epub 2006 Apr 20.
12823906

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D003550	Cystic Fibrosis
D001249	Asthma