Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

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.

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Key information

Conditions

Rhinitis, Allergic Asthma Asthma, Allergic Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique - Hopitaux de Marseille, Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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

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

Biological

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

Primary outcomes

Proteomic profile of each patient

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

Acronym: VAPARA

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Apr 15, 2010
Registry last updated: Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed