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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01104012
First received: April 8, 2010
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Rhinitis, Allergic
Asthma, Allergic
 Biological: Classification as "asthmatic" or "rhinitis only" via proteomic analysis
Biological: Classification as "asthmatic" or "rhinitis only" according to a metacholine test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Proteomic profile of each patient [ Time Frame: One day (snapshot) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

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.


Enrollment: 133
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients
Allergy patients, asthma and rhinitis
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104012

Locations
France
Assistance Publique - Hopitaux de Marseille
Marseille, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Nicolas Molinari, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01104012     History of Changes
Other Study ID Numbers: PHRC-I/2009/NM-01, 2009-A00399-48
Study First Received: April 8, 2010
Last Updated: March 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013