Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
VAPARA
The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
2 other identifiers
observational
133
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 27, 2015
March 1, 2015
2.4 years
April 8, 2010
March 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
All patients
Allergy patients, asthma and rhinitis
Interventions
Proteomic profiles are established for each patient using plasma and serum samples
A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.
Eligibility Criteria
The asthma and allergic rhinitis patients included in this study are recruted from the Pneumology Departments of the University Hospitals of Nîmes, Marseilles, and Montpellier.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Assistance Publique - Hopitaux de Marseille
Marseille, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029, France
Biospecimen
Serum and plasma samples are taken on patient inclusion. For the purposes of this study, only proteomic profiles via SELDI-TOF will be characterized. Excess serum and plasma will be stored in the CHU de Nîmes Biothèque.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Molinari, PhD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 15, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
March 27, 2015
Record last verified: 2015-03