We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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:


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

Primary Outcome Measures:
  • 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.


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: October 2012
Primary Completion Date: October 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), RCB Number )
First Submitted: April 8, 2010
First Posted: April 15, 2010
Last Update Posted: March 27, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic
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