NCT00356629

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

First QC Date

July 25, 2006

Last Update Submit

November 13, 2008

Conditions

Keywords

bronchopulmonary ignitioncondensate of exhaled airMucoviscidosisAsthma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ubjects suffering from CF, COPD, asthma and tobacco exposure

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie et EFR CHRU Tours

Tours, 37044, France

Location

Related Publications (2)

  • 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.

    PMID: 16627747BACKGROUND
  • Grimbert D, Vecellio L, Delepine P, Attucci S, Boissinot E, Poncin A, Gauthier F, Valat C, Saudubray F, Antonioz P, Diot P. Characteristics of EPI-hNE4 aerosol: a new elastase inhibitor for treatment of cystic fibrosis. J Aerosol Med. 2003 Summer;16(2):121-9. doi: 10.1089/089426803321919889.

    PMID: 12823906BACKGROUND

Related Links

MeSH Terms

Conditions

Cystic FibrosisAsthma

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • DIOT Patrice, Pr

    service de Pneumologie et EFR CHRU Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

July 1, 2006

Study Completion

July 1, 2008

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations