Rhinitis, AllergicVAPARANCT01104012
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
An observational study of Rhinitis, Allergic and Asthma, Allergic, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Asthma, Allergic
- What is being tested?
- Classification as "asthmatic" or "rhinitis only" via proteomic analysis and Classification as "asthmatic" or "rhinitis only" according to a metacholine test
- How many people
- 133 participants
- Where
- 3 sitesFrance
- Study dates
- May 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Assistance Publique - Hopitaux de Marseille
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
About this study
Official title: 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.
- Conditions
- Rhinitis, Allergic, Asthma, Allergic
- Being tested
- Classification as "asthmatic" or "rhinitis only" via proteomic analysis, Classification as "asthmatic" or "rhinitis only" according to a metacholine test
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classification as "asthmatic" or "rhinitis only" via proteomic analysisBiological
Proteomic profiles are established for each patient using plasma and serum samples
Classification as "asthmatic" or "rhinitis only" according to a metacholine testBiological
A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Allergy patients, asthma and rhinitis Receives: Biological: Classification as "asthmatic" or "rhinitis only" via proteomic analysis; Biological: Classification as "asthmatic" or "rhinitis only" according to a metacholine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day (snapshot)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Molinari, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104012
- Sponsor's protocol ID
- PHRC-I/2009/NM-01
- Other IDs
- 2009-A00399-48
- Acronym
- VAPARA
- Status last verified
- Mar 2015
- First submitted
- 8 Apr 2010
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
- ClinicalTrials.gov ID
- NCT01104012
- Acronym / sponsor ID
- VAPARA / PHRC-I/2009/NM-01
- Conditions
- Rhinitis, Allergic, Asthma, Allergic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Biological: Classification as "asthmatic" or "rhinitis only" via proteomic analysis, Biological: Classification as "asthmatic" or "rhinitis only" according to a metacholine testAllergy patients, asthma and rhinitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classification as "asthmatic" or "rhinitis only" via proteomic analysisProteomic profiles are established for each patient using plasma and serum samples | Biological | All patients |
| Classification as "asthmatic" or "rhinitis only" according to a metacholine testA positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma. | Biological | All patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
Related trials for Rhinitis, Allergic
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Molinari, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic and Asthma, Allergic, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic profile of each patient (time frame: One day (snapshot)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.