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

November 13, 2008 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Service de Pneumologie et EFR CHRU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ubjects suffering from CF, COPD, asthma and tobacco exposure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

November 14, 2008

Last Update Submitted That Met QC Criteria

November 13, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOHP06-PD Air Exhalé

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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