Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study

ConditionAllergies
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

Apple-birch pollen-food allergy syndrome is particularly common in Northern and Central Europe (70% of patients allergic to birch pollen), and classically induces an oral syndrome that impairs patients' quality of life. Current treatment is based on food avoidance. However, evidence of the efficacy of this treatment is limited (small numbers, lack of validation with a control group, absence of double-blind evaluation of the primary endpoint in a challenge test against placebo). The aim of oral immunotherapy with raw apple is to improve the management of allergic patients by enabling them to acquire tolerance to raw apple and other rosacea.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with allergic rhinitis to birch pollen.

Patient with an oral syndrome within 15 minutes of consuming at least one of the first 3 doses of raw apple in the V0 or V1 raw apple oral challenge test.

Evidence of sensitization to PR10 proteins in birch pollen and apple: positive prick tests to birch pollen and raw Golden apple and/or positive Bet v 1 and Mal d 1 specific IgE assays.

Subject affiliated to a social health insurance scheme

Disqualifiers

Severe or uncontrolled asthma

Severe obstructive syndrome

Active neoplastic disease

Active autoimmune disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • oral provocation test

    Other intervention

    Progressively increasing doses of peeled fresh Golden apple or placebo will be consumed by the patient (4g, 12g, 40g, 120g) with a time interval of 20 minutes between each dose.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: oral immunotherapyExperimental treatment 1 intervention
Group B: evictionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome

To evaluate the efficacy of oral immunotherapy to raw apple on the reduction of oral raw apple syndrome after 9 months of oral immunotherapy. A reduction in oral syndrome after 9 months of oral immunotherapy with raw apple is defined as: absence of oral syndrome on the 9-month raw apple OPT when consuming a dose of raw apple 3 times greater than the dose of raw apple triggering oral syndrome on the initial raw apple oral challenge.

Time frame
9 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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