Can we Help People With the Oral Allergy Syndrome Eat Fresh Fruit?

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Royal Sussex County Hospital
Sponsor:
Information provided by (Responsible Party):
Nicola Gray, Royal Sussex County Hospital
ClinicalTrials.gov Identifier:
NCT01431859
First received: September 5, 2011
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

Birch pollen allergy is increasingly common. It causes asthma and early season hay fever. This is because the body recognises birch pollen and reacts to it, leading to symptoms. Many patients with birch allergy get an itchy and/or swollen mouth when they eat fresh fruit (apples, pears, peaches, plums etc). Some fruit proteins have a similar structure to birch pollen; because of this the body recognises these proteins too causing the immune system to respond. This response causes symptoms of itch and swelling inside the mouth and throat. the investigators want to find out whether it is possible to get rid of the fruit-induced symptoms by using a desensitisation procedure that has been developed for treating the kind of hay fever that is caused by birch pollen. Desensitisation involves giving a small injection of pollen just under the skin and gradually increasing the amount each week. This allows the body to build up a "tolerance" to the injected protein. When the pollen is then encountered in real life the immune system reacts less vigorously so symptoms are less severe. This treatment does reduce hay fever symptoms. Our study aims to find out if this tolerance is transferred to the fruit proteins enabling patients to eat apples with minimal symptoms. Patients will be given apple to eat in a hidden form before treatment and their response assessed. They will then receive either active or dummy pollen injections before birch pollen season. A few months after completing these injections they will have another disguised apple test to see whether their symptoms are any better. If symptoms have improved with treatment then this therapy could be offered to patients in the future. This would allow them to eat fresh fruit without worrying about unpleasant symptoms and improve their hay fever symptoms.


Condition Intervention Phase
Oral Allergy Syndrome
Biological: Allergovit Birch pollen
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blind Placebo Controlled Randomised Trial to Study the Effects of Birch Pollen Specific Immunotherapy (BP-SIT) on the Symptoms of the Oral Allergy Syndrome in Adult Patients

Resource links provided by NLM:


Further study details as provided by Royal Sussex County Hospital:

Primary Outcome Measures:
  • Change in threshold for eating uncooked apple from baseline, compared to 1 year and 2 years following the intervention. [ Time Frame: baseline, 1 year and 2 years ] [ Designated as safety issue: No ]

    Baseline measurements will be taken in Winter 2012 assessing the tolerance to fresh apple in a double blind placebo controlled manner. The intervention will start in January 2013.

    Outcomes will be assessed using the double blind placebo controlled food challenge technique in Winter 2013 and 2014. (1 and 2 years after baseline assessment)



Secondary Outcome Measures:
  • Change in symptoms of rhinoconjunctivitis immediately after the first season of immunotherpay compared to 2 seasons of immunotherapy treatment. [ Time Frame: baseline, 1 year and 2 years ] [ Designated as safety issue: No ]
    Diary cards will be given to patients to complete in the first season following immunotherapy, to assess hay fever symptoms.

  • Change in conjunctival provocation tests from baseline. [ Time Frame: baseline, 1 year and 2 years ] [ Designated as safety issue: No ]
    Conjunctival provocation testing will take place at baseline in Winter 2012 using standard birch pollen exracts. Repeat tests will occur Winter 2013 and 2014 to assess changes following the intervention.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Subcutaneous injection of placebo Other: Placebo
Placebo injection to be given subcutaneously once weekly for 7 weeks prior to birch pollen season for 2 consecutive years.
Active Comparator: Birch pollen immunotherapy Biological: Allergovit Birch pollen
Birch pollen specific immunotherapy. Once weekly injection for 7 weeks prior to birch pollen season for 2 consecutive seasons

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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 (auto-immune or thyroid disease, immunodeficiency)
  • 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 misuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431859

Contacts
Contact: Anthony J Frew, MBBS MD FRCP 01273 696955 anthony.frew@bsuh.nhs.uk
Contact: Nicola J Gray, MBBS BSc 01273 696955 ext 3665 nicola.gray@bsuh.nhs.uk

Locations
United Kingdom
Royal Sussex County Hospital Recruiting
Brighton, East Sussex, United Kingdom, BN2 5BE
Contact: Nicola J Gray, MBBS    01273 696955 ext 3529    nicola.gray@bsuh.nhs.uk   
Principal Investigator: Anthony J Frew, MBBS MD FRCP         
Sub-Investigator: Michael Tarzi, MBBS MD FRCPath         
Sub-Investigator: Nicola J Gray, MBBS MRCP         
Sponsors and Collaborators
Royal Sussex County Hospital
Investigators
Principal Investigator: Anthony Frew, MBBS MD FRCP Brighton and Sussex University Hospital Trust
  More Information

No publications provided

Responsible Party: Nicola Gray, Clinical Research Fellow, Royal Sussex County Hospital
ClinicalTrials.gov Identifier: NCT01431859     History of Changes
Other Study ID Numbers: 10/143/FREW, 2011-004078-26
Study First Received: September 5, 2011
Last Updated: November 30, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Royal Sussex County Hospital:
pollen
allergy
food
immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Syndrome
Disease
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014