Can we Help People With the Oral Allergy Syndrome Eat Fresh Fruit?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01431859|
Recruitment Status : Active, not recruiting
First Posted : September 12, 2011
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Oral Allergy Syndrome||Biological: Allergovit Birch pollen Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
|Placebo Comparator: Subcutaneous injection of placebo||
Placebo injection to be given subcutaneously once weekly for 7 weeks prior to birch pollen season for 2 consecutive years.
|Active Comparator: Birch pollen immunotherapy||
Biological: Allergovit Birch pollen
Birch pollen specific immunotherapy. Once weekly injection for 7 weeks prior to birch pollen season for 2 consecutive seasons
- 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)
- 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 ]Diary cards will be given to patients to complete in the first season following immunotherapy, to assess hay fever symptoms.
- Change in conjunctival provocation tests from baseline. [ Time Frame: baseline, 1 year and 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431859
|Royal Sussex County Hospital|
|Brighton, East Sussex, United Kingdom, BN2 5BE|
|Principal Investigator:||Anthony Frew, MBBS MD FRCP||Brighton and Sussex University Hospital Trust|