Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

Rhinitis, Allergic Clinical Trial

— VAPARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104012
• Other study ID #: PHRC-I/2009/NM-01
• Secondary ID: 2009-A00399-48
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: March 26, 2015
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma
• Asthma, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• Classification as "asthmatic" or "rhinitis only" via proteomic analysis
Proteomic profiles are established for each patient using plasma and serum samples
• 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.

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Marseille	Marseille
France	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	Centre Hospitalier Universitaire de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic profile of each patient	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.	One day (snapshot)	No