Enabling people with oral allergy syndrome to eat fresh fruit

Phase 1

• Conditions: Oral allergy syndrome; MedDRA version: 15.1 Level: HLGT Classification code 10001708 Term: Allergic conditions System Organ Class: 10021428 - Immune system disorders; MedDRA version: 15.1 Level: PT Classification code 10068355 Term: Oral allergy syndrome System Organ Class: 10021428 - Immune system disorders; MedDRA version: 15.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-004078-26-GB
• Lead Sponsor: Brighton & Sussex University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-05
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Male or female; age 18 with no upper age limit History of typical fruit-related symptoms on eating apples plus or minus other plant-derived foods known to be involved in the pollen-food syndrome History of spring rhinitis hay fever Positive skin prick test to birch pollen Positive open food challenge to apple
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Significant medical conditions that may affect the risks of giving BP-SIT (especially uncontrolled asthma or ongoing need for beta-blockers) History of moderate to severe systemic reaction to apple, defined as any of: generalised urticaria, generalised angioedema, history convincing for laryngeal oedema, collapse Current immunological disease Malignant disease within the past five years (Patients with previous malignant disease that is considered cured, may be included subject to the consent of their oncologist) Inability to attend regularly for injections and follow-up visits Severe atopic dermatitis Previous immunotherapy with birch pollen extract Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide) Breast-feeding Evidence of current drug or alcohol abuse Involvement in another trial of an investigational medicinal product within 4 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): A change in sensitivity to uncooked apple, after therapy, compared to pre-treatment threshold;Timepoint(s) of evaluation of this end point: Approximately 6 months following the last injection of Birch pollen specific immunotherapy.;Secondary Objective: 1.Does the birch pollen immunotherapy have an effect on rhinitis and conjunctivitis symptoms in real life? 2.Is there a change in the conjunctival provocation tests? 3.Does the patients immune response in the blood change following immunotherapy? 4.Are these changes (if any) related to the patient's ability to eat apples?;Main Objective: Does immunotherapy (the process of giving small but increasing doses of birch pollen as injections under the skin) improve symptoms of mouth and throat itch, irritation and swelling on eating apples in patients with oral allergy syndrome?

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Is there an improvement in symptoms of rhinitis during hay fever season? Symptoms will be recorded in a diary from mid-March to mid-May to cover the birch pollen season. Is there a change in the conjunctival provocation tests (CPTs)? The concentration of pollen that elicits a score of 4 or more is recorded as the provocation threshold. We are looking for an increase in this threshold after treatment. Antibody and cellular measures We will test for levels of IgE and IgG antibodies against birch pollen and apple. We can then see whether the changes in blood are linked to the patients’ ability to tolerate apples.;Timepoint(s) of evaluation of this end point: Diary cards will be analysed after 1 and 2 seasons of immunotherapy as will the CPTs. Blood tests will be taken at 12 points throughout the trial and batch analysis will be performed at the end of the 2 year study.