Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

Completed

• Conditions: Asthma, Allergic; Rhinitis, Allergic
• Interventions: Biological: Classification as "asthmatic" or "rhinitis only" via proteomic analysis; Biological: Classification as "asthmatic" or "rhinitis only" according to a metacholine test

• Registration Number: NCT01104012
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Study Start: 2010-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Classification as "asthmatic" or "rhinitis only" via proteomic analysis	Allergy patients, asthma and rhinitis
All patients	Classification as "asthmatic" or "rhinitis only" according to a metacholine test	Allergy patients, asthma and rhinitis

Primary Outcome Measures

Name	Time	Method
Proteomic profile of each patient	One day (snapshot)	The attribution of a proteomic profile as either "asthmatic" or "rhinitis". Proteomic profiles are determined accordig to the SELDI-TOF method. This is a transversal study validating proteomic profiles as a new diagnostic test.

Trial Locations

Locations (3)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, France

Assistance Publique - Hopitaux de Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, France