Peanut Allergy Clinical Trial
Official title:
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | Inclusion Criteria: - medical history of peanut allergy, - IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method), - reaction to less than 100 mg of peanut protein during OOFC, - signed Informed Consent by parent/legal guardian and patient aged >16 years old, - patient's/caregivers' cooperation with researcher. Exclusion Criteria: - no confirmed peanut allergy, - negative oral food challenge with less than 100mg of peanut protein, - severe asthma, - uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5. percentile), FEV1/forced vital capacity (FVC)<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months, - current oral/sublingual/subcutaneous immunotherapy with other allergen, - eosinophilic gastroenteritis, - a history of severe recurrent anaphylaxis episodes, - chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes, - medication: - oral, daily steroid therapy longer than 1 month within last 12 months, - at least two courses of oral steroid therapy (at least 7 days) within last 12 months, - oral steroid therapy longer than 7 days within last 3 months, - biological treatment, - the need to constantly take antihistamines, - therapy with ß-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors, - pregnancy, - no consent to participate in the study, - lack of patient cooperation. |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW; ARC001 Study Group. Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):476-485.e3. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31. — View Citation
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Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009. — View Citation
Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5. — View Citation
PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18. — View Citation
Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance of peanuts | Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein | Up to 16 months after starting oral immunotherapy | |
Secondary | Adverse event | quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category | Up to 16 months after starting oral immunotherapy | |
Secondary | Laboratory data | difference in peanut serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment | Up to 16 months after starting oral immunotherapy | |
Secondary | Skin prick test (SPT) | change in skin prick test reactivity to peanut protein from baseline to end of treatment, compared between groups | Up to 16 months after starting oral immunotherapy |
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