The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire

This study has been completed.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00854958
First received: March 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition
Food Allergy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: May 2005
Study Completion Date: September 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult subjects aged over 18 years recruited from the general population

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854958

Locations
United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Stephen R Durham, BA, MA, MD, Imperial College London
  More Information

No publications provided by Royal Brompton & Harefield NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Isabel Skypala, Director of Rehabilitation and Therapies, Royal Brompton & Harefield NHS Trust
ClinicalTrials.gov Identifier: NCT00854958     History of Changes
Other Study ID Numbers: 05/Q0404/38
Study First Received: March 2, 2009
Last Updated: March 2, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Oral
Allergy
Syndrome
Food
Pollen

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 28, 2014