Nut Allergy Clinical Trial
Official title:
Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy
Nut sensitization in skin prick tests is common in areas, including Finland, where birch pollen is abundant. However, sensitization to nuts in skin prick test does not predict the possibility of allergic symptoms when nuts are ingested. In this study the investigators launch and perform double-blind placebo-controlled nut challenges and oral desensitization/ protocol to those with serious symptoms in the challenge. The efficacy and safety of the new oral desensitization program is the primary outcome. The effect of oral desensitization on bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are secondary outcomes.
Status | Completed |
Enrollment | 102 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: - sensitization in skin prick test or in serum nut-specific IgE - unknown anaphylaxis suspected caused by nuts - never eaten nuts - if challenge positive with serious symptoms, OIT Exclusion Criteria: - active asthma and low lung function, - pregnancy, cardiovascular or other disease that might worsen during the challenge and OIT |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central Hospital, Skin and Allergy Hospital | Helsinki | |
Finland | Helsinki University Central Hospital, Skin and Allergy Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of nut oral desensitization | Change from baseline in the amount of nut (mg) tolerated in a double-blind placebo-controlled oral challenge at 1 month after the 6-month oral desensitization therapy. | 7 months | No |
Secondary | Effect of the treatment on quality of life | Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy | 7 months | No |
Secondary | Effect of the treatment on bronchial hyperreactivity and airway inflammation | Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid | 1 year | Yes |
Secondary | Safety of nut oral desensitization therapy | Number of participants with adverse events as a measure of safety and tolerability | 7 months | Yes |
Secondary | Effect of the treatment on eosinophilic airway inflammation | Change from baseline in exhaled nitric oxid concentration | 1 year | Yes |
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