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Biodistribution of Neutrophile Proteases in the Sputum of Patients Affected by Cystic Fibrosis (Pro-Muco)

This study is currently recruiting participants.
Verified by University Hospital, Tours, September 2008

Sponsored by: University Hospital, Tours
Information provided by: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00750932
  Purpose

The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue.

The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results.

The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.


Condition
Cystic Fibrosis

Genetics Home Reference related topics:   cystic fibrosis   

MedlinePlus related topics:   Cystic Fibrosis   

ChemIDplus related topics:   Serine    Proteinase, serine   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Study of the Biodistribution of PMN Serine Proteases in Sputum of Patients Affected by Cystic Fibrosis: Towards New Anti-Inflammatory Therapies

Further study details as provided by University Hospital, Tours:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Whole blood Sputum


Estimated Enrollment:   90
Study Start Date:   January 2008

Groups/Cohorts
T
Control
M
Minor with cystic fibrosis
A
Adult with cystic fibrosis

  Eligibility
Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Adults and children with cystic fibrosis


Criteria

Inclusion Criteria:

  • Man /woman older than 18 years (for adult and group)
  • Child aged 6 to 18 years (for child group)
  • Suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks

Exclusion Criteria:

  • colonized by Burkholderia cepacia ou Stenotrophomonas maltophilia
  • non smoker (control group)
  • Without history or respiratory respiratory disease known (control group)
  • Antibiotic treatment and / or anti-inflammatory drug (NSAID or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750932

Contacts
Contact: Patrice DIOT, PHD     +33247473787     diot@med.univ-tours.fr    
Contact: Pascaline RAMEAU     +33247474664     rameau@med.univ-tours.fr    

Locations
France
CHRU de Tours     Recruiting
      TOURS, France, 37044
      Contact: Patrice DIOT, PHD     +33247473787     diot@med.univ-tours.fr    
      Contact: Pascaline Rameau     +33247474664     rameau@med.univ-tours.fr    
      Principal Investigator: Patrice DIOT, PHD            
      Sub-Investigator: Francoise Varaigne, MD            
      Sub-Investigator: Charlotte GIRAUT, MD            
      Sub-Investigator: Sophie MARCHAND, MD            

Sponsors and Collaborators
University Hospital, Tours

Investigators
Principal Investigator:     Patrice DIOT, PHD     Tours Hospital    
Principal Investigator:     Patrice DIOT, PHD     Tours Hospital    
  More Information


Responsible Party:   University Hospital, Tours ( University Hospital, Tours )
Study ID Numbers:   AOHP07-PD Pro-Muco, DGS2007-0295, N° ID RCB:2007-A00511-52, CPP: 2007-R17
First Received:   September 10, 2008
Last Updated:   September 10, 2008
ClinicalTrials.gov Identifier:   NCT00750932
Health Authority:   France: Ministry of Health

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 06, 2008




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