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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00750932
First received: September 10, 2008
Last updated: November 13, 2008
Last verified: November 2008
  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

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Biospecimen Retention:   Samples With DNA

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
Sub-Investigator: David GENDRE, MD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Patrice DIOT, PHD Tours Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00750932     History of Changes
Other Study ID Numbers: AOHP07-PD Pro-Muco, DGS2007-0295, N° ID RCB:2007-A00511-52, CPP: 2007-R17
Study First Received: September 10, 2008
Last Updated: November 13, 2008
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 22, 2014