Asthma, Inflammation and G Protein-coupled Receptors (GPCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Strasbourg, France
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00793676
First received: November 17, 2008
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

The G protein-coupled receptors (GPCRs) are a family of proteins expressed at the cell membrane. They are composed of 380 members involved in the important functions of the organism and are privileged therapeutic targets.Their expression is highly modulated depending on the metabolic state of the cells, in particular in pathological situations.our study proposes to determine whether GPCR expression modulation could be used as a biomarker, either prognostic or diagnostic, of treatments.To do so , the investigators will determine the expression profile of the 380 human GPCRs in human blood cell samples in two chronic inflammatory pulmonary diseases : asthma and COPD (chronic obstructive pulmonary disease ) . These have opposed inflammatory infiltrates : asthma is associated with eosinophil and Th2 lymphocyte infiltration whereas COPD shows neutrophils and macrophages within the airways with a Th1 lymphocytic population. The GPCR signature (transcriptomic) will be determined on total white blood cells as well as on isolated mono- and poly-nuclear populations obtained from healthy subjects and patients selected at the asthma or COPD consultation. The expression profiling analysis will reveal sub-groups of GPCRs whose expression is modified in disease. The specificity of the variation of expression of these biomarker sub-populations will be determined, by a study recruiting a hundred patients and controls per disease on this restraint number of genes. The outcomes of the project will lead to establish GPCR "identity cards" for these chronic inflammatory diseases, which might therefore be used as diagnostic or prognostic biomarkers to follow the evolution of a disease or the efficacy of a given treatment. In addition, detailed analysis of the identified GPCRs will lead to propose new therapeutic targets for inflammatory diseases. This study has therefore the objective of validating GPCRs as potential biomarkers for inflammatory diseases.


Condition Intervention
Asthma
COPD
Other: spirometry
Other: blood test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: G Protein Coupled Receptor (GPCR)Signature as Biomarker of Chronic Pulmonary Inflammatory Diseases and of Therapeutic Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • differential expression of GPCRs [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 310
Study Start Date: September 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A= Asthma Other: spirometry Other: blood test
B= COPD Other: blood test
C= Control Other: blood test

Detailed Description:

Multicentre non-randomized

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Asthma group
  • COPD group
  • Control group

Exclusion Criteria:

  • Patients with infection or inflammatory diseases
  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: NCT00793676

Contacts
Contact: Romain Kessler, MD 0369550377 ext 0033 romain.kessler@chru-strasbourg.fr

Locations
France
Hospital Not yet recruiting
Colmar, France, 68024
Contact: Jean philippe Oster, MD         
Sub-Investigator: Jean Philippe Oster, MD         
Pascal Chanez Recruiting
Marseille, France, 13008
Contact: Pascal Chanez, MD    04 91 74 46 30 ext 0033    pascal.chanez@univmed.fr   
University Hospital Not yet recruiting
Montpellier, France, 34295
Contact: Arnaud Bourdin, MD         
Sub-Investigator: Arnaud Bourdin, MD         
Antoine Magnan Recruiting
Nantes, France, 44035
Contact: Antoine Magnan, MD    02 40 16 52 35 ext 0033    antoine.magnan@nantes.inserm.fr   
University Hospital, Strasbourg, France Recruiting
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Strasbourg, France
National Research Agency, France
Investigators
Principal Investigator: Romain Kessler, MD University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00793676     History of Changes
Other Study ID Numbers: 4171
Study First Received: November 17, 2008
Last Updated: June 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
GPCR expression
transcriptomic
white blood cells
diagnostic
Control

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014