Oral Allergy SyndromePhase 4NCT01431859
Can we Help People With the Oral Allergy Syndrome Eat Fresh Fruit?
A Phase 4 study testing Allergovit Birch pollen in people with Oral Allergy Syndrome, run by Royal Sussex County Hospital at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Allergy Syndrome
- What is being tested?
- Allergovit Birch pollen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Nov 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE
About this study
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
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.
- Conditions
- Oral Allergy Syndrome
- Being tested
- Allergovit Birch pollen, Placebo
- Keywords
- pollen, allergy, food, immunotherapy
- Medical subject headings
- Oral Allergy Syndrome, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovit Birch pollenBiological
Birch pollen specific immunotherapy. Once weekly injection for 7 weeks prior to birch pollen season for 2 consecutive seasons
PlaceboOther
Placebo injection to be given subcutaneously once weekly for 7 weeks prior to birch pollen season for 2 consecutive years.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous injection of placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Birch pollen immunotherapy | Active comparator | Not described Receives: Biological: Allergovit Birch pollen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in threshold for eating uncooked apple from baseline, compared to 1 year and 2 years following the intervention.
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)
Measured: baseline, 1 year and 2 years
Secondary outcomes (2)
Change in symptoms of rhinoconjunctivitis immediately after the first season of immunotherpay compared to 2 seasons of immunotherapy treatment.
Diary cards will be given to patients to complete in the first season following immunotherapy, to assess hay fever symptoms.
Measured: baseline, 1 year and 2 years
Change in conjunctival provocation tests from baseline.
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.
Measured: baseline, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startJul 2012
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Allergy SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Sussex County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Gray, Royal Sussex County Hospital
- Investigators
- Anthony Frew, MBBS MD FRCP, Principal investigator, Brighton and Sussex University Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431859
- Sponsor's protocol ID
- 10/143/FREW
- Other IDs
- 2011-004078-26
- Status last verified
- Apr 2016
- First submitted
- 5 Sep 2011
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01431859
- Acronym / sponsor ID
- 10/143/FREW
- Conditions
- Oral Allergy Syndrome
- Keywords
- pollen, allergy, food, immunotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Sussex County HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 12 Sep 2011 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous injection of placebo | Placebo comparator | Other: Placebo |
| Birch pollen immunotherapy | Active comparator | Biological: Allergovit Birch pollen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergovit Birch pollenBirch pollen specific immunotherapy. Once weekly injection for 7 weeks prior to birch pollen season for 2 consecutive seasons | Biological | Birch pollen immunotherapy |
| PlaceboPlacebo injection to be given subcutaneously once weekly for 7 weeks prior to birch pollen season for 2 consecutive years. | Other | Subcutaneous injection of placebo |
Primary outcome
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
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)
2 secondary outcomes
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
Change in conjunctival provocation tests from baseline.
Time frame: baseline, 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
Anthony Frew, MBBS MD FRCP principal investigator
Brighton and Sussex University Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allergovit Birch pollen in people with Oral Allergy Syndrome, run by Royal Sussex County Hospital 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
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 6 Apr 2016.