Clinical Trial: Nut Allergy Study: Double-blind Challenge and Oral Desensitization

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy

Brief Summary: 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.

Detailed Summary: The investigators aim to improve nut allergy diagnosis by launching a new double-blind placebo-controlled nut (peanut, hazel nut, cashew) challenge protocol. The investigators also launch a specific oral tolerance induction (SOTI) protocol to nuts in serious nut allergy. This study takes place in the Helsinki University Skin and Allergy Hospital between May 2011 and December 2015. Inclusion criteria: age 6 to 18 years and suspected nut allergy (unclear anaphylaxis possibly caused by nuts, skin prick test to nuts ≥ 10 mm or specific-IgE ≥ 20 kU/L and have never eaten nuts, or avoids nuts and does not dare try nuts at home). Patients having uncontrolled asthma or other lung disease, having cardiovascular disease or other systemic disease, using beta-blockers, and having poor compliance, are excluded. Methods:The investigators perform skin prick tests to peanut, tree nuts and seeds, take a blood sample before the double-blind placebo-controlled food challenges (DBPCFC), and measure total IgE and specific-IgE to birch, peanut, hazel nut, allergen components Ara h 1, 2, 3, and 8, and Cor a 1 and 8. Then the serum samples are kept frozen for further component and immunologic analyses. The investigators put iv before the challenge. In DBPCFC the patients receive 5 mg, 50 mg, 200mg, and 1000mg nut protein mixt with placebo, or placebo every 30 minutes. The severity of the allergic reaction is estimated using a modified severity scale. The probability of severe/moderate reaction at low (<0.7 kU/L) and at increased (>0.7 kU/L) Ara h 2 and 8 concentrations is the primary end-point in the DBPCFC. The investigators also correlate the concentrations of Ara h 2 with the severity score. Patients with moderate or severe reaction in the challenge will be offered desensitization therapy "SOTI" using(pea)nut flour mixed with milk-free margarine. The first dose of 0.1 mg nut protein is given at hospital part of the up-dosing is made at home every 2 weeks. The
Sponsor: Helsinki University Central Hospital

Current Primary Outcome: Efficacy of nut oral desensitization [ Time Frame: 7 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of the treatment on quality of life [ Time Frame: 7 months ]
    Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
  • Effect of the treatment on bronchial hyperreactivity and airway inflammation [ Time Frame: 1 year ]
    Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
  • Safety of nut oral desensitization therapy [ Time Frame: 7 months ]
    Number of participants with adverse events as a measure of safety and tolerability
  • Effect of the treatment on eosinophilic airway inflammation [ Time Frame: 1 year ]
    Change from baseline in exhaled nitric oxid concentration


Original Secondary Outcome:

  • Effect of the treatment on quality of life [ Time Frame: 7 months ]
    Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
  • Effect of the treatment on bronchial hyperreactivity and airway inflammation [ Time Frame: 1 year ]
    Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
  • Safety of nut oral desensitization therapy [ Time Frame: 7 months ]
    Number of participants with adverse events as a measure of safety and tolerablilty
  • Effect of the treatment on eosinophilic airway inflammation [ Time Frame: 1 year ]
    Change from baseline in exhaled nitric oxid concentration


Information By: Helsinki University Central Hospital

Dates:
Date Received: May 27, 2011
Date Started: May 2011
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016