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Validation of Proteomic Analyses for Allergic Asthma and Rhinitis (VAPARA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104012
First Posted: April 15, 2010
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
April 8, 2010
April 15, 2010
March 27, 2015
May 2010
October 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01104012 on ClinicalTrials.gov Archive Site
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Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
The VAPARA Study: 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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
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.
Non-Probability Sample
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.
  • Rhinitis, Allergic
  • Asthma, Allergic
  • Biological: Classification as "asthmatic" or "rhinitis only" via proteomic analysis
    Proteomic profiles are established for each patient using plasma and serum samples
  • 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.
All patients
Allergy patients, asthma and rhinitis
Interventions:
  • Biological: Classification as "asthmatic" or "rhinitis only" via proteomic analysis
  • Biological: Classification as "asthmatic" or "rhinitis only" according to a metacholine test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01104012
PHRC-I/2009/NM-01
2009-A00399-48 ( Other Identifier: Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), RCB Number )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Nicolas Molinari, PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2015