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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Ignition Condensate of Exhaled Air Mucoviscidosis Asthma

Keywords

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bronchopulmonary ignition condensate of exhaled air Mucoviscidosis Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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University Hospital Tours

Principal Investigators

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DIOT Patrice, Pr

Role: PRINCIPAL_INVESTIGATOR

service de Pneumologie et EFR CHRU Tours

Locations

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Service de Pneumologie et EFR CHRU Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND

PMID: 16627747 (View on PubMed)

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.