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

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ClinicalTrials.gov Identifier: NCT00356629
Recruitment Status : Terminated (Technical problem)
First Posted : July 26, 2006
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:

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
Bronchopulmonary Ignition Condensate of Exhaled Air Mucoviscidosis Asthma

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
Estimated 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 : July 2006
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ubjects suffering from CF, COPD, asthma and tobacco exposure
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356629


Locations
France
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
More Information

Additional Information:
Publications:
Responsible Party: University Hospital Tours/Jocelyne Marlière, University Hospital Tours
ClinicalTrials.gov Identifier: NCT00356629     History of Changes
Other Study ID Numbers: AOHP06-PD Air Exhalé
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by University Hospital, Tours:
bronchopulmonary ignition
condensate of exhaled air
Mucoviscidosis
Asthma

Additional relevant MeSH terms:
Inflammation
Pneumonia
Cystic Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases