Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 randomised controlled trial
| Autor: | Loraine Foley, John Deighton, Simon Bond, Sabita Islam, Pamela Ewan, Christopher R. Palmer, Laura Pasea, Katherine Anagnostou, Y. King, Andrew Clark |
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| Rok vydání: | 2014 |
| Předmět: |
Male
Allergy medicine.medical_specialty Adolescent Peanut allergy Administration Oral law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Humans Medicine Peanut Hypersensitivity Child Skin Tests 030304 developmental biology Medicine(all) 0303 health sciences Cross-Over Studies Intention-to-treat analysis business.industry food and beverages General Medicine medicine.disease Crossover study 3. Good health Surgery Clinical trial Treatment Outcome Clinical research England 030228 respiratory system Desensitization Immunologic Quality of Life Population study Female Immunotherapy business |
| Zdroj: | The Lancet. 383(9925):1297-1304 |
| ISSN: | 0140-6736 |
| DOI: | 10.1016/s0140-6736(13)62301-6 |
| Popis: | SummaryBackgroundSmall studies suggest peanut oral immunotherapy (OIT) might be effective in the treatment of peanut allergy. We aimed to establish the efficacy of OIT for the desensitisation of children with allergy to peanuts.MethodsWe did a randomised controlled crossover trial to compare the efficacy of active OIT (using characterised peanut flour; protein doses of 2–800 mg/day) with control (peanut avoidance, the present standard of care) at the NIHR/Wellcome Trust Cambridge Clinical Research Facility (Cambridge, UK). Randomisation (1:1) was by use of an audited online system; group allocation was not masked. Eligible participants were aged 7–16 years with an immediate hypersensitivity reaction after peanut ingestion, positive skin prick test to peanuts, and positive by double-blind placebo-controlled food challenge (DBPCFC). We excluded participants if they had a major chronic illness, if the care provider or a present household member had suspected or diagnosed allergy to peanuts, or if there was an unwillingness or inability to comply with study procedures. Our primary outcome was desensitisation, defined as negative peanut challenge (1400 mg protein in DBPCFC) at 6 months (first phase). Control participants underwent OIT during the second phase, with subsequent DBPCFC. Immunological parameters and disease-specific quality-of-life scores were measured. Analysis was by intention to treat. Fisher's exact test was used to compare the proportion of those with desensitisation to peanut after 6 months between the active and control group at the end of the first phase. This trial is registered with Current Controlled Trials, number ISRCTN62416244.FindingsThe primary outcome, desensitisation, was recorded for 62% (24 of 39 participants; 95% CI 45–78) in the active group and none of the control group after the first phase (0 of 46; 95% CI 0–9; p |
| Databáze: | OpenAIRE |
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