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

NCT06771791 | Recruiting Phase 3

• 1 other identifier: 9432
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergies

Keywords

allergy; oral immunotherapy

Outcome Measures

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.

  9 month

Study Arms (2)

oral immunotherapy

EXPERIMENTAL

oral immunotherapy with raw apple during 9 month

Other: oral provocation test

eviction

PLACEBO COMPARATOR

avoidance of raw apples for 9 months

Other: oral provocation test

Interventions

oral provocation test OTHER

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.

eviction; oral immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67000, France

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Anays PIOTIN, Dr

CONTACT

+33 03.69.55.00.49; anays.piotin@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

FR (1)