Nut Allergy Study: Double-blind Challenge and Oral Desensitization

Nut Allergy Clinical Trial

Official title:

Nut Allergy Study: Improving Diagnosis And Treatment Of Nut Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502878
• Other study ID #: HUCHT101060080
• Secondary ID: IAS11
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: September 12, 2016
• Start date: May 2011
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

Description:

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 patient takes an antihistamine 1 hour before each daily dose. An epinephrine autoinjector and prednisolone tablets are also prescribed for emergency use. The desensitization protocol takes 28 weeks and is personalized when needed. Exercise is avoided 1 hour following each dose. Before and after the SOTI the investigators measure food related quality of life using standardized questionnaires, and perform metacholine challenge and measure exhaled nitric oxid. After the SOTI the investigators take blood samples and perform DBPCFC again.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Nut Allergy
• Nut Hypersensitivity

Intervention

Dietary Supplement:
• Nut challenge
Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding
• Nut challenge: Placebo
Dried banana mixed with oat yoghurt or chocolate pudding
• Nut oral desensitization
Roasted peanut powder mixed with milk- and soy-free margarine

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Skin and Allergy Hospital	Helsinki
Finland	Helsinki University Central Hospital, Skin and Allergy Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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