RhinitisNCT00427479
Oral Allergy Syndrome (OAS): a Pilot Study to Evaluate a Clinical Questionnaire as a Diagnostic Tool
An observational study of Rhinitis and Food Allergy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
An increasing number of people have an allergy to birch pollen, which manifests itself as Springtime hayfever. Some will also have cross-reactions to fruits, vegetables and nuts, a condition known as Oral Allergy Syndrome (OAS). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Food Allergy
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2002to Dec 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- History of Springtime hayfever
- Positive skin prick test ( 3mm) to Birch
- FEV1 > than 70% predicted or greater than 1.5L
- Aged 16 years or more
Who cannot join
- Pregnancy
- Existing medical condition which could be affected by a severe response on challenge
- Aged under 16
- FEV1 < than 70% predicted or greater than 1.5L
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton & Harefield NHS TRust
London, SW3 6NP
About this study
Official title: The Prevalence of Oral Allergy Syndrome and Types of Food Commonly Causing Reactions in Birch Pollen Sensitive Patients Who Have Springtime Hayfever
An increasing number of people have an allergy to birch pollen, which manifests itself as Springtime hayfever. Some will also have cross-reactions to fruits, vegetables and nuts, a condition known as Oral Allergy Syndrome (OAS). Research has demonstrated that the most effective method of diagnosing this problem is by taking a good clinical history and performing skin prick tests using fresh foods.
The aim of the study will be therefore to investigate the prevalence of OAS in a birch-sensitive population using a simple screening tool and establish the range of foods involved. The objective will be to maximise effective treatment for the patients in our large respiratory allergy clinic by using the screening tool to identify patients with OAS and advise them on the usual foods involved. A further objective will be to use the data to discover if there are any patterns of particular foods involved in OAS in UK sufferers.
The study hypotheses are therefore that there is a high prevalence of oral allergy in people with birch pollen allergy; the best way of diagnosing the problem is by using a screening tool and that there is a core set of foods that are commonly involved in OAS in patients seen in the allergy clinic.
Read the detailed description
Patients will be recruited both prospectively and retrospectively from the Royal Brompton Hospital allergy clinic and through advertisement. Subjects will be identified by diagnosis of birch pollen allergy, either routinely in the RBHT adult allergy clinic or by looking back at patient records. Suitable patients will be invited to participate in the study, with fully informed consent obtained, if they understand written English and fulfil the following criteria:
Criteria for inclusion
- History of Springtime hayfever
- Positive skin prick test ( 3mm) to Birch
- FEV1.> than 70% predicted or greater than 1.5L
- Aged 16 years or more
Exclusion criteria
- Pregnancy
- Existing medical condition which could be affected by a severe response on challenge
- Aged under 16
- FEV1.< than 70% predicted or greater than 1.5L
On recruitment
After a full explanation of the study given, patients who agree to participate will be asked to sign the consent form, a copy of which will be placed in the medical notes, and a second copy sent to the Ethics Committee Administrator. Participants will then be booked in for visit one and advised to avoid short acting antihistamines for 72 hours and long acting ones for a week, prior to their prick prick test.
The OAS screening tool will be completed for every patient. A venous blood sample will be taken and stored for the measurement of total IgE and specific IgE RAST tests for birch, apple, celery and hazelnuts. A questionnaire will be completed by the patient assessing the effect any food reactions is having on their diet and social life. The researcher will then complete a 24-hour food recall questionnaire with the patient, to ascertain their normal dietary intake.
The patient will then be asked whether they have taken anti-histamines in the last 72 hours, and if they have not then prick prick tests can be performed using a range of different fresh fruits, vegetables, nuts and Birch and Grass reagent. The tests will be undertaken according to EAACI recommendations, with a positive and negative control. The allergen content of fresh foods is unknown, but using data from previous studies, a wheal of 3mm will be considered positive, and a wheal of 5 mm strongly positive.
All participants will then be invited to return to undergo one single blind, placebo food challenge. Those classed as negative responders will then undergo two double blind, placebo-controlled food challenges (DBPCFC), one being an active substance and one a control substance. Following these challenges, those still classed as negative responders will undergo an open challenge with the active substance. The only exclusion criteria will be those subjects who have previously reported an anaphylactic response to the active challenge material.
- Conditions
- Rhinitis, Food Allergy
- Keywords
- Allergy, Food, Hay fever, Screening
- Medical subject headings
- Rhinitis, Food Hypersensitivity, Hypersensitivity, Rhinitis, Allergic, Seasonal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJul 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Isabel J Skypala, BSc, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427479
- Sponsor's protocol ID
- 2002UR005B
- Status last verified
- Jan 2007
- First submitted
- 26 Jan 2007
- Last updated
- 29 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Oral Allergy Syndrome and Types of Food Commonly Causing Reactions in Birch Pollen Sensitive Patients Who Have Springtime Hayfever
- ClinicalTrials.gov ID
- NCT00427479
- Acronym / sponsor ID
- 2002UR005B
- Conditions
- Rhinitis, Food Allergy
- Keywords
- Allergy, Food, Hay fever, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Dec 2003
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An increasing number of people have an allergy to birch pollen, which manifests itself as Springtime hayfever. Some will also have cross-reactions to fruits, vegetables and nuts, a condition known as Oral Allergy Syndrome (OAS). Research has demonstrated that the most effective method of diagnosing this problem is by taking a good clinical history and performing skin prick tests using fresh foods.
The aim of the study will be therefore to investigate the prevalence of OAS in a birch-sensitive population using a simple screening tool and establish the range of foods involved. The objective will be to maximise effective treatment for the patients in our large respiratory allergy clinic by using the screening tool to identify patients with OAS and advise them on the usual foods involved. A further objective will be to use the data to discover if there are any patterns of particular foods involved in OAS in UK sufferers.
The study hypotheses are therefore that there is a high prevalence of oral allergy in people with birch pollen allergy; the best way of diagnosing the problem is by using a screening tool and that there is a core set of foods that are commonly involved in OAS in patients seen in the allergy clinic.
Detailed description
Patients will be recruited both prospectively and retrospectively from the Royal Brompton Hospital allergy clinic and through advertisement. Subjects will be identified by diagnosis of birch pollen allergy, either routinely in the RBHT adult allergy clinic or by looking back at patient records. Suitable patients will be invited to participate in the study, with fully informed consent obtained, if they understand written English and fulfil the following criteria:
Criteria for inclusion
- History of Springtime hayfever
- Positive skin prick test ( 3mm) to Birch
- FEV1.> than 70% predicted or greater than 1.5L
- Aged 16 years or more
Exclusion criteria
- Pregnancy
- Existing medical condition which could be affected by a severe response on challenge
- Aged under 16
- FEV1.< than 70% predicted or greater than 1.5L
On recruitment
After a full explanation of the study given, patients who agree to participate will be asked to sign the consent form, a copy of which will be placed in the medical notes, and a second copy sent to the Ethics Committee Administrator. Participants will then be booked in for visit one and advised to avoid short acting antihistamines for 72 hours and long acting ones for a week, prior to their prick prick test.
The OAS screening tool will be completed for every patient. A venous blood sample will be taken and stored for the measurement of total IgE and specific IgE RAST tests for birch, apple, celery and hazelnuts. A questionnaire will be completed by the patient assessing the effect any food reactions is having on their diet and social life. The researcher will then complete a 24-hour food recall questionnaire with the patient, to ascertain their normal dietary intake.
The patient will then be asked whether they have taken anti-histamines in the last 72 hours, and if they have not then prick prick tests can be performed using a range of different fresh fruits, vegetables, nuts and Birch and Grass reagent. The tests will be undertaken according to EAACI recommendations, with a positive and negative control. The allergen content of fresh foods is unknown, but using data from previous studies, a wheal of 3mm will be considered positive, and a wheal of 5 mm strongly positive.
All participants will then be invited to return to undergo one single blind, placebo food challenge. Those classed as negative responders will then undergo two double blind, placebo-controlled food challenges (DBPCFC), one being an active substance and one a control substance. Following these challenges, those still classed as negative responders will undergo an open challenge with the active substance. The only exclusion criteria will be those subjects who have previously reported an anaphylactic response to the active challenge material.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- History of Springtime hayfever
- Positive skin prick test ( 3mm) to Birch
- FEV1 > than 70% predicted or greater than 1.5L
- Aged 16 years or more
Key exclusion criteria (4 listed)
- Pregnancy
- Existing medical condition which could be affected by a severe response on challenge
- Aged under 16
- FEV1 < than 70% predicted or greater than 1.5L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2007.
Related trials for Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel J Skypala, BSc principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis and Food Allergy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2007.