Clinical trial NCT00854958: The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
Official title: The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: Oral
Allergy
Syndrome
Food
Pollen
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects aged over 18 years recruited from the general population

Brief summary: Oral allergy syndrome is a type of food allergy which mainly affects people with springtime hay fever. It is caused by a cross-reaction, between antibodies to pollens, usually birch tree pollen, and allergens in many different plant foods. It is characterised by symptoms of itching and/or swelling in the mouth and/or throat when eating certain fruits vegetables and nuts. Many of the allergens causing OAS are destroyed by heat, making allergy testing using traditional allergen extracts unreliable. Prick testing or challenging with fresh foods is more reliable, but time consuming, inconvenient and largely unavailable. Pilot study results suggest the characteristic symptoms and foods involved in OAS allow accurate diagnosis using clinical history alone, which forms the basis for the hypothesis of this proposal that OAS can be diagnosed accurately by use of a validated questionnaire alone. The diagnostic questionnaire (PFSDQ), revised from the results of the pilot study, will be tested against two reference test methods, the gold standard of oral food challenge, and the 'platinum standard' of diagnosis made by a medical expert based on history, skin prick testing and oral food challenge. This is not an epidemiological study but with no published studies on OAS in a UK population, this study will also provide some information on the prevalence of OAS in those with springtime hayfever in the UK.


Eligibility criteria: Inclusion Criteria:

* symptoms of seasonal allergic rhino-conjunctivitis with/without seasonal asthma from March to May

Exclusion Criteria:

* below the age of 18 years, had poorly controlled concomitant asthma (Forced Expiratory Volume in one second (FEV1) \<70% predicted), any significant pre-existing medical condition, were pregnant or required β-blocking agents, H1-receptor antagonists or glucocorticosteroids on a continuous basis.

Primary outcomes:
measure: The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis.
timeFrame: 18 months
Secondary outcomes:
measure: The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome
timeFrame: 18 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Trust
Study officials:
affiliation: Imperial College London
name: Stephen R Durham, BA, MA, MD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skypala IJ, Calderon MA, Leeds AR, Emery P, Till SJ, Durham SR. Development and validation of a structured questionnaire for the diagnosis of oral allergy syndrome in subjects with seasonal allergic rhinitis during the UK birch pollen season. Clin Exp Allergy. 2011 Jul;41(7):1001-11. doi: 10.1111/j.1365-2222.2011.03759.x. Epub 2011 Apr 25.