NCT00715156

Brief Summary

This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

July 14, 2008

Last Update Submit

February 20, 2012

Conditions

Keywords

allergy, peach, birchrecombinants allergens diagnosisOASLTPsystemic reactionssubjects with severe reaction to other fruits

Outcome Measures

Primary Outcomes (1)

  • Evaluation of diagnostic efficacy of PHADIA IMMUNO-CAP with the peach recombinant allergens Pru p 3, 1 and 4 as compared to peach IMMUNO-CAP in the identification of peach allergic subjects at major risk of anaphylaxis

    1 year

Secondary Outcomes (1)

  • Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits

    1 year

Study Arms (2)

A

Subjects with mild (S1) reaction to peach fruit

B

Subjects with severe reaction to peach fruit

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Peach allergic subjects at major risk of anaphylaxis

You may qualify if:

  • female and male;
  • pts with 18 e 80 years old;
  • signature of the informed consent form;
  • CAP/RAST positive for peach;
  • clinical manifestation of peach allergy

You may not qualify if:

  • pregnancy;
  • current antihistamine therapy;
  • subjects that do not give consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niguarda Hospital

Milan, Italy, 20162, Italy

Location

Related Publications (2)

  • Pastorello EA, Farioli L, Pravettoni V, Scibilia J, Mascheri A, Borgonovo L, Piantanida M, Primavesi L, Stafylaraki C, Pasqualetti S, Schroeder J, Nichelatti M, Marocchi A. Pru p 3-sensitised Italian peach-allergic patients are less likely to develop severe symptoms when also presenting IgE antibodies to Pru p 1 and Pru p 4. Int Arch Allergy Immunol. 2011;156(4):362-72. doi: 10.1159/000324440. Epub 2011 Aug 9.

  • Mascheri A, Farioli L, Pravettoni V, Piantanida M, Stafylaraki C, Scibilia J, Mirone C, Preziosi D, Nichelatti M, Pastorello EA. Hypersensitivity to Tomato (Lycopersicon esculentum) in Peach-Allergic Patients: rPrup 3 and rPrup 1 Are Predictive of Symptom Severity. J Investig Allergol Clin Immunol. 2015;25(3):183-9.

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Food HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Elide A Patorello, MD

    Niguarda Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 15, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

November 1, 2010

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations