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NCT00356629 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00356629
Other study ID # AOHP06-PD Air Exhalé
Secondary ID
Status Terminated
Phase N/A
First received July 25, 2006
Last updated November 13, 2008
Start date July 2006
Est. completion date July 2008

Study information
Verified date November 2008
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date July 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Pneumologie et EFR CHRU Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (2)

Attucci S, Gauthier A, Korkmaz B, Delépine 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. Epub 2006 Apr 20. — View Citation

Grimbert D, Vecellio L, Delépine 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. — View Citation

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