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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Completed

CT.gov ID

NCT00793676

Collaborator

National Research Agency, France (Other)

205

Enrollment

Locations

Arms

108

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Asthma COPD	Other: spirometry Other: blood test	N/A

Detailed Description

Multicentre non-randomized

Study Design

Study Type:

Interventional

Actual Enrollment :

205 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: A= Asthma	Other: spirometry Other: blood test
Other: B= COPD	Other: blood test
Other: C= Control	Other: blood test

Arm

Intervention/Treatment

Other: A= Asthma

Other: spirometry

Other: blood test

Other: B= COPD

Other: blood test

Other: C= Control

Other: blood test

Outcome Measures

Primary Outcome Measures

differential expression of GPCRs [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Asthma group
COPD group
Control group

Exclusion Criteria:

Patients with infection or inflammatory diseases

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital	Colmar	France	68024
2	Pascal Chanez	Marseille	France	13008
3	University Hospital	Montpellier	France	34295
4	Antoine Magnan	Nantes	France	44035
5	University Hospital, Strasbourg, France	Strasbourg	France	67000