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

Inclusion criteria

• 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
• Subject able to understand the aims and risks of the research and to give dated and signed informed consent
• For women of childbearing age: negative urine pregnancy test at inclusion visit

Exclusion criteria

• Severe or uncontrolled asthma
• Severe obstructive syndrome
• Active neoplastic disease
• Active autoimmune disease
• Eosinophilic esophagitis or other active eosinophilic gastrointestinal pathologies
• History of bariatric surgery
• History of anaphylaxis to apples
• Allergy to cooked apples
• Contraindication to anti-histamines, corticoids, salbutamol, adrenaline
• Other contraindication to an oral challenge test
• Allergy to placebo ingredients
• Presence of oral syndrome during consumption of placebo in the first oral challenge test
• Allergenic immunotherapy to birch pollen in progress or completed less than 5 years ago
• Current treatment with anti-IgE, anti-IL4/13, anti-IL5 or anti-TSLP biotherapy.
• Impossibility of giving the subject informed information
• Subject under court protection
• Subject under guardianship or curatorship
• Pregnancy