Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

NCT ID: NCT01104012

Last Updated: 2015-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.

Detailed Description

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Conditions

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Rhinitis, Allergic Asthma, Allergic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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All patients

Allergy patients, asthma and rhinitis

Classification as "asthmatic" or "rhinitis only" via proteomic analysis

Intervention Type BIOLOGICAL

Proteomic profiles are established for each patient using plasma and serum samples

Classification as "asthmatic" or "rhinitis only" according to a metacholine test

Intervention Type BIOLOGICAL

A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.

Interventions

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Classification as "asthmatic" or "rhinitis only" via proteomic analysis

Proteomic profiles are established for each patient using plasma and serum samples

Intervention Type BIOLOGICAL

Classification as "asthmatic" or "rhinitis only" according to a metacholine test

A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* signed consent
* never-smokers or non-smoking for at least 2 years + \< 5 packs per year
* capable of understanding the study
* patient is affiliated with a social security system
* positive skin tests (at least one for Montpellier region pneumoallergens)
* treated with nasal or inhaled corticoids, leucotriene receptor antagonists, anti-IgE, Theophylline, anti-histamines, sodium cromoglycate, beta-blockers, benzodiazépine, oral corticoids: all these treatments must be interrupted for at least 72 hours

Exclusion Criteria

* Co-morbidities: none; no co-morbidities are accepted
* dental infections (any) during the 3 months preceding the study
* suspected alcoholism or drug abuse
* chronic viral infection (hepatitis, HIV)
* patient under guardianship
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Molinari, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Assistance Publique - Hopitaux de Marseille

Marseille, , France

Site Status

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status

Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00399-48

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2009/NM-01

Identifier Type: -

Identifier Source: org_study_id

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