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

Sponsor
University Hospital, Tours (Other)
Overall Status
Terminated
CT.gov ID
NCT00356629
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Development of a Noninvasive Method of Evaluation of the Pulmonary Inflammation in the Condensates of Exhaled Air
    Study Start Date :
    Jul 1, 2006
    Anticipated Study Completion Date :
    Jul 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes

      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Service de Pneumologie et EFR CHRU Tours Tours France 37044

      Sponsors and Collaborators

      • University Hospital, Tours

      Investigators

      • Principal Investigator: DIOT Patrice, Pr, service de Pneumologie et EFR CHRU Tours

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00356629
      Other Study ID Numbers:
      • AOHP06-PD Air Exhalé
      First Posted:
      Jul 26, 2006
      Last Update Posted:
      Nov 14, 2008
      Last Verified:
      Nov 1, 2008

      Study Results

      No Results Posted as of Nov 14, 2008