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

March 2, 2009
March 2, 2009
May 2005
September 2006   (final data collection date for primary outcome measure)
The validation of the OAS diagnostic questionnaire (PFSDQ) against accepted standard methods of diagnosis. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
The characterisation of the pollen and aeroallergen sensitivities of those diagnosed with roal allergy syndrome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire
The Diagnosis of Oral Allergy Syndrome Through the Use of a Structured Questionnaire

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

Adult subjects aged over 18 years recruited from the general population

Food Allergy
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
September 2007
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00854958
05/Q0404/38
No
Isabel Skypala, Director of Rehabilitation and Therapies, Royal Brompton & Harefield NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Not Provided
Principal Investigator: Stephen R Durham, BA, MA, MD, Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP