Peanut Allergies in Children Clinical Trial
Official title:
A Prospective, Randomized, Case Controlled, Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization in Children With Peanut Allergies.
The primary objective of this study is to evaluate, compared to non-treatment, the impact of a titrated dose (1 mg once a day, then 1 mg twice a day and finally a full 2 mg twice a day) of ketotifen on the adverse event profile emerging from a rapid peanut desensitization protocol, in children with established peanut allergy.
The development of a safe oral peanut challenge procedure permits patients that do not have
severe life threatening allergic reactions, to be safely desensitized with the ability to
maintain peanut tolerance . The peanut desensitization procedure is however associated with
unpleasant allergic side effects mainly gastrointestinal and cutaneous manifestations. The
use of premedication drugs may lessen these side effects and facilitate the peanut
desensitization procedure. Ketotifen is a fast acting, noncompetitive, H1-receptor blocker
(antihistamine/inverse agonist) that also inhibits the release of mediators from mast cells
involved in hypersensitivity reactions.
The study will enroll 6 (4 in the peanut treatment group, 2 in the control group) children
with a known history of peanut allergies. The treated subjects will be randomized in a 2:1
ratio into either a pre-treatment group (final dose of 2 mg bid ketotifen) or a control
group. All subjects will undergo a one-day peanut desensitization protocol designed to
enable the subject to tolerate 50 mg of peanut flour (initial escalation phase). After the
initial escalation day achieving up to 50 mg of peanut flour, the dosing build-up will occur
every two weeks through 44 weeks. Subjects will ingest the 50mg and increased doses of
peanut flour at home (every day for 2 weeks) between each dose escalation. The target dose
is 8000 mg of peanut flour. A maintenance dose will be given for 4 weeks following the last
(highest dose) visit.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment